Delayed Bleeding, Post-Polypectomy Syndrome, Post Procedural Complication, Procedural Bleeding
Conditions
Brief summary
EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larger flat lesions as it provides submucosal lift of polyps, adenomas, other gastrointestinal mucosal lesions or early-stage cancers prior to EMR. This has been found to minimize mechanical or electrocautery damage to the deep layers of the gastrointestinal tract wall as the injectate provides a safety cushion as such between the area to be removed and healthy mucosal tissue. Several solutions are used today for injecting lesions including saline, hyaluronic acid, and hydroxyethyl starch (Hetastarch). Saline solution has been found to dissipate within minutes, which may result in a lower quality lesion lift. Hyaluronic acid provides a longer lift, but is expensive and is not readily available in the U.S. A new injectate known as Eleview has been developed for use in gastrointestinal endoscopic procedures and recently approved by the FDA. This injectate boasts a cushion of excellent height and duration through the use of an oil-in-water emulsion. However, the initial cost of this material is quite high ($80 per 10 ml). Hetastarch, which is the current injectate used by Dr Rex, is a safe and considerably inexpensive solution that provides prolonged submucosal elevation and lowers procedure times. Our study will aim to compare Eleview to Hetastarch in the hopes of finding the ideal submucosal injectate. This trial will focus on polyps of size ≥11 mm removed by snare EMR technique. Patients with lesions deemed not suitable for EMR due to features suggestive of sub-mucosal invasion will not be included.
Detailed description
Injectate randomization: Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in a 1:1 ratio. Randomization will occur at the site using envelopes provided by the Investigator. The envelope's contents will specify the treatment assignment for each patient and opened by the research team (PI will be blinded). The investigators will monitor the safety and effectiveness data. The appropriate solutions will be injected into the submucosal space beneath the lesion(s) to be excised before the lesion(s) is/are removed. Subjects in both groups will receive the appropriate volume of injectate deemed necessary by the PI for the individual patient. Sample size and Statistical Analysis At least 200 patients will be enrolled. 100 of these patients will be randomized to Eleview injectate and 100 will be given the standard of care, Hetastarch injectate only. Efficacy and safety of Eleview injectate has only been reviewed in one previous study. Therefore, the planned sample size was not calculated using a statistical power analysis, but was regarded as sufficient to repeat the objectives of the COSMO study (2017) and satisfy the exploratory purposes of the present study. Study personnel will carry out a simple randomization using a commonly used online generator. Randomization assignments will then be sealed until day of procedure until patient eligibility has been confirmed. The Principal Investigator will remain blinded and will perform all data analysis after completion of the study. Data will be summarized and compared using classic descriptive statistics, i.e. mean, standard deviation, coefficient of variation (%), minimum, median and maximum values for quantitative variables, and frequencies for qualitative variables. The Sydney Resection Quotient will be compared between treatment groups using a Wilcoxon Rank-Sum test. The proportion of subjects with en bloc resection of all endoscopically visible lesions will also be compared between treatment groups using a Fisher's exact test. A nominal alpha level of 0.05 will be used for both the comparisons. No formal comparison will be performed for the secondary endpoints.
Interventions
DRUGEleview
If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
DRUGHetastarch
If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The Investigator is blinded to the randomization process but can be unblinded after the product has been dispensed if the patient has a medical issue that requires it.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Sex and age: men and women \> 18 years old 2. Subjects referred for EMR of polyps of size ≥11 mm 3. ASA score 1, 2 or 3. 4. Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care). 5. Subject is willing and able to participate in the study procedures and to understand and sign the informed consent
Exclusion criteria
1. Age: Subjects is under 18 years old 2. Consent: Vulnerable subjects including those who are unable to consent 3. Pregnancy: Pregnant or breastfeeding women 4. ASA score \<3 5. Physical findings: Abnormal physical findings that may interfere with the study objectives 6. Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days 7. Excluded lesions: * Lesions less than 11 mm in largest dimension * Lesions involving the muscularis propria (T2 lesions) * Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma * Proven malignant disease locally advanced or with metastasis * Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease * Endoscopic appearance of invasive malignancy 8. Previous partial resection or attempted resection of the lesion 9. Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs 10. Severe liver disease. 11. Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon, 12. Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease 13. Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR\>1.5). 14. Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study. 15. Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sydney Resection Quotient (SRQ) | During the large polyp removal | Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Injected Volume Needed for Complete Removal of Lesion | During the large polyp removal | Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch |
| Number of Re-injections Needed During Resection | During the large polyp removal | Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection. |
| Number of En Bloc Resections | During the large polyp removal | Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch |
| Number of Pieces Resected Using Snares | During the large polyp removal | Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch. |
| Mound Concentration Diameter | During the large polyp removal | Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be. |
| Injected Volume Needed for Initial Lesion Lift | During initial injection portion of large polyp removal | Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch. |
| Mound Duration | During the large polyp removal | Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating. |
| Ease of Injection | During the large polyp removal | Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult. |
| Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | During the large polyp removal | Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect. |
| Time Required to Remove the Lesion | During the large polyp removal | Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion) |
| Safety Outcomes as Assessed by Complications During or After the Procedure | during large polyp removal through 30 days post procedure | To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate. |
| Mound Concentration Height | During the large polyp removal | Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eleview This arm will be administered the Eleview Injectate (up to 50 mL's) solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Eleview: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. | 77 |
| Hetastarch This arm will be administered Hetastarch (w/Methylene blue as a contrast agent) as the injection solution upon randomization, provided the lesion is equal to or greater than 11 millimeters.
Hetastarch: If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion. | 81 |
| Total | 158 |
Baseline characteristics
| Characteristic | Eleview | Hetastarch | Total |
|---|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 8.3 | 65.6 Years STANDARD_DEVIATION 10.3 | 66.4 Years STANDARD_DEVIATION 9.4 |
| Number of lesions randomized in the study | 114 Lesions | 102 Lesions | 159 Lesions |
| Race/Ethnicity, Customized Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 24 Participants | 17 Participants | 41 Participants |
| Race/Ethnicity, Customized White | 52 Participants | 64 Participants | 116 Participants |
| Region of Enrollment United States | 77 participants | 81 participants | 158 participants |
| Sex: Female, Male Female | 43 Participants | 39 Participants | 82 Participants |
| Sex: Female, Male Male | 34 Participants | 42 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 81 |
| other Total, other adverse events | 16 / 77 | 15 / 81 |
| serious Total, serious adverse events | 0 / 77 | 0 / 81 |
Outcome results
Primary
Sydney Resection Quotient (SRQ)
Comparison of the Sydney Resection Quotient between EMRs done using Eleview vs EMRs done using Hetastartch as the injection fluid. The Sydney Resection Quotient (SRQ) is the size of the polyp divided by the number of pieces in which the polyp was resected. A larger SRQ is better than a smaller SRQ.
Time frame: During the large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Sydney Resection Quotient (SRQ) | Adenomas | 9.3 Ratio | Standard Deviation 6.2 |
| Eleview | Sydney Resection Quotient (SRQ) | Serrated | 12.3 Ratio | Standard Deviation 4 |
| Hetastarch | Sydney Resection Quotient (SRQ) | Adenomas | 8.1 Ratio | Standard Deviation 4.9 |
| Hetastarch | Sydney Resection Quotient (SRQ) | Serrated | 11.1 Ratio | Standard Deviation 6.5 |
Secondary
Ease of Injection
Comparison of how easily the fluid was able to be injected. This was rated by the endoscopy technician assisting in the large polyp removal. It was rated on the following scale: Very Easy, Easy, Difficult, Very Difficult.
Time frame: During the large polyp removal
Population: Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Ease of Injection | Easy | 58 Polyps |
| Eleview | Ease of Injection | Very difficult | 0 Polyps |
| Eleview | Ease of Injection | Difficult | 3 Polyps |
| Eleview | Ease of Injection | Unknown | 1 Polyps |
| Eleview | Ease of Injection | Very easy | 52 Polyps |
| Hetastarch | Ease of Injection | Unknown | 1 Polyps |
| Hetastarch | Ease of Injection | Very easy | 46 Polyps |
| Hetastarch | Ease of Injection | Easy | 52 Polyps |
| Hetastarch | Ease of Injection | Difficult | 3 Polyps |
| Hetastarch | Ease of Injection | Very difficult | 0 Polyps |
Secondary
Injected Volume Needed for Complete Removal of Lesion
Comparison of the volume of injection fluid needed for complete removal of lesion between Eleview and Hetastarch
Time frame: During the large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Injected Volume Needed for Complete Removal of Lesion | Adenomas | 14.8 milliliters | Standard Deviation 13.1 |
| Eleview | Injected Volume Needed for Complete Removal of Lesion | Serrated Lesions | 7.8 milliliters | Standard Deviation 5.7 |
| Hetastarch | Injected Volume Needed for Complete Removal of Lesion | Adenomas | 20.6 milliliters | Standard Deviation 20.9 |
| Hetastarch | Injected Volume Needed for Complete Removal of Lesion | Serrated Lesions | 10.7 milliliters | Standard Deviation 8.8 |
Secondary
Injected Volume Needed for Initial Lesion Lift
Comparison of the volume of injection fluid needed for initial lesion lift of Eleview vs Hetastarch.
Time frame: During initial injection portion of large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Injected Volume Needed for Initial Lesion Lift | Adenomas | 10.4 milliliters | Standard Deviation 5.4 |
| Eleview | Injected Volume Needed for Initial Lesion Lift | Serrated | 7.1 milliliters | Standard Deviation 4.9 |
| Hetastarch | Injected Volume Needed for Initial Lesion Lift | Adenomas | 11.6 milliliters | Standard Deviation 7 |
| Hetastarch | Injected Volume Needed for Initial Lesion Lift | Serrated | 8.7 milliliters | Standard Deviation 4.3 |
Secondary
Mound Concentration Diameter
Comparison fluid behavior and ease of use between Eleview and Hetastarch rated on a 3-point scale (Excellent, Sufficient, or Inadequate). The more the fluid spread out laterally after being injected, the worse the rating would be. The more the fluid stayed concentrated around the polyp after injection, the better the rating would be.
Time frame: During the large polyp removal
Population: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Mound Concentration Diameter | Excellent | 64 Polyps |
| Eleview | Mound Concentration Diameter | Sufficient | 41 Polyps |
| Eleview | Mound Concentration Diameter | Inadequate | 9 Polyps |
| Hetastarch | Mound Concentration Diameter | Excellent | 54 Polyps |
| Hetastarch | Mound Concentration Diameter | Sufficient | 41 Polyps |
| Hetastarch | Mound Concentration Diameter | Inadequate | 7 Polyps |
Secondary
Mound Concentration Height
Comparison of how well the injection fluid lifted the polyp during the large polyp removal between Eleview and Hetastarch rated by the following scale: Excellent, Sufficient, Inadequate. The more the polyp was able to be lifted vertically, the better the rating would be.
Time frame: During the large polyp removal
Population: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Mound Concentration Height | Sufficient | 37 Polyps |
| Eleview | Mound Concentration Height | Inadequate | 10 Polyps |
| Eleview | Mound Concentration Height | Excellent | 67 Polyps |
| Hetastarch | Mound Concentration Height | Sufficient | 38 Polyps |
| Hetastarch | Mound Concentration Height | Inadequate | 6 Polyps |
| Hetastarch | Mound Concentration Height | Excellent | 58 Polyps |
Secondary
Mound Duration
Comparison of how long the injection fluid was able to keep the polyp lifted during the large polyp removal between Eleview and Hetastarch. This was rating using the following scale: Excellent, Sufficient, or Inadequate. The longer the injection fluid stayed concentrated and kept the polyp lifted, the better rating it received while rapid dissipation of the fluid would receive a worse rating.
Time frame: During the large polyp removal
Population: Since some patients had more than one eligible polyp included in the study, there are 114 polyps but only 77 patients in the Eleview arm and 102 polyps but only 81 patients in the Hetastarch arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Mound Duration | Excellent | 60 Polyps |
| Eleview | Mound Duration | Sufficient | 41 Polyps |
| Eleview | Mound Duration | Inadequate | 11 Polyps |
| Eleview | Mound Duration | Unknown | 2 Polyps |
| Hetastarch | Mound Duration | Unknown | 0 Polyps |
| Hetastarch | Mound Duration | Excellent | 58 Polyps |
| Hetastarch | Mound Duration | Inadequate | 5 Polyps |
| Hetastarch | Mound Duration | Sufficient | 39 Polyps |
Secondary
Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation.
Need for additional treatments relating to the polyp resection such as avulsion, coagulation or ablation. These treatments can be done in addition to endoscopic mucosal resection (EMR) in order to remove polyp tissue/treat the defect.
Time frame: During the large polyp removal
Population: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | avulsion | 37 Polyps requiring additional treatments |
| Eleview | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | soft coagulation | 72 Polyps requiring additional treatments |
| Eleview | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | ablation | 9 Polyps requiring additional treatments |
| Hetastarch | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | avulsion | 36 Polyps requiring additional treatments |
| Hetastarch | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | soft coagulation | 55 Polyps requiring additional treatments |
| Hetastarch | Need for Additional Treatments Relating to the Polyp Resection Such as Avulsion, Coagulation or Ablation. | ablation | 7 Polyps requiring additional treatments |
Secondary
Number of En Bloc Resections
Comparison of the number of polyps that were able to be removed in one piece during the resection between polyps injected with Eleview and polyps injected with Hetastarch
Time frame: During the large polyp removal
Population: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 84 adenomas and 30 serrated lesions included in the Eleview arm. For the same reason, there are 81 patients but 75 adenomas and 27 serrated lesions in the Hetastarch group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Number of En Bloc Resections | Adenomas | 18 Polyps |
| Eleview | Number of En Bloc Resections | Serrated Lesions | 2 Polyps |
| Hetastarch | Number of En Bloc Resections | Adenomas | 14 Polyps |
| Hetastarch | Number of En Bloc Resections | Serrated Lesions | 2 Polyps |
Secondary
Number of Pieces Resected Using Snares
Comparison of the number of pieces removed using snare between polyps injected with Eleview compared with polyps injected with Hetastarch.
Time frame: During the large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Number of Pieces Resected Using Snares | Adenomas | 4.5 polyp pieces resected | Standard Deviation 5 |
| Eleview | Number of Pieces Resected Using Snares | Serrated Lesions | 7 polyp pieces resected | Standard Deviation 5.9 |
| Hetastarch | Number of Pieces Resected Using Snares | Adenomas | 5.5 polyp pieces resected | Standard Deviation 5.3 |
| Hetastarch | Number of Pieces Resected Using Snares | Serrated Lesions | 8.2 polyp pieces resected | Standard Deviation 7 |
Secondary
Number of Re-injections Needed During Resection
Comparison of the number of re-injections needed during the large polyp removal. Number of re-injections is the number of times the injection device is passed down the scope to inject the polyp after initial injection during the large polyp resection.
Time frame: During the large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Number of Re-injections Needed During Resection | Adenomas | 0.61 reinjections | Standard Deviation 1.3 |
| Eleview | Number of Re-injections Needed During Resection | Serrated Lesions | 0.1 reinjections | Standard Deviation 0.31 |
| Hetastarch | Number of Re-injections Needed During Resection | Adenomas | 1.01 reinjections | Standard Deviation 1.6 |
| Hetastarch | Number of Re-injections Needed During Resection | Serrated Lesions | 0.3 reinjections | Standard Deviation 0.9 |
Secondary
Safety Outcomes as Assessed by Complications During or After the Procedure
To evaluate the safety of Eleview for EMR procedures in relation to adverse events and occurrence of complications during and after the EMR procedure in comparison to Hetastarch injectate.
Time frame: during large polyp removal through 30 days post procedure
Population: There were 77 patients in the Eleview arm of the study. Since some patients had more than one eligible polyp for the study, there ended up being 114 lesions included in the Eleview arm. For the same reason, there are 81 patients but 102 polyps in the Hetastarch group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Eleview | Safety Outcomes as Assessed by Complications During or After the Procedure | Intraprocedural bleeding | 18 Polyps |
| Eleview | Safety Outcomes as Assessed by Complications During or After the Procedure | Delayed Bleeding | 1 Polyps |
| Eleview | Safety Outcomes as Assessed by Complications During or After the Procedure | Post procedure abdonimal pain | 0 Polyps |
| Eleview | Safety Outcomes as Assessed by Complications During or After the Procedure | Perforation | 1 Polyps |
| Hetastarch | Safety Outcomes as Assessed by Complications During or After the Procedure | Perforation | 0 Polyps |
| Hetastarch | Safety Outcomes as Assessed by Complications During or After the Procedure | Intraprocedural bleeding | 14 Polyps |
| Hetastarch | Safety Outcomes as Assessed by Complications During or After the Procedure | Post procedure abdonimal pain | 1 Polyps |
| Hetastarch | Safety Outcomes as Assessed by Complications During or After the Procedure | Delayed Bleeding | 1 Polyps |
Secondary
Time Required to Remove the Lesion
Time (in minutes) to remove the lesion completely (measured from the first injection to final excision of the lesion)
Time frame: During the large polyp removal
Population: Some patients had more than one eligible polyp for the study so there ended up being 84 adenomas and 30 serrated lesions in the Eleview arm and 75 adenomas and 27 serrated lesions in the Hetastarch arm. The number of patients within a column doesn't equal the number of overall patients in the arm because some had both types of polyps.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Eleview | Time Required to Remove the Lesion | Adenomas | 14.8 minutes | Standard Deviation 11.4 |
| Eleview | Time Required to Remove the Lesion | Serrated Lesions | 5.9 minutes | Standard Deviation 4.2 |
| Hetastarch | Time Required to Remove the Lesion | Serrated Lesions | 7.1 minutes | Standard Deviation 9.1 |
| Hetastarch | Time Required to Remove the Lesion | Adenomas | 16.02 minutes | Standard Deviation 13.9 |