Endoscopic Mucosal Resection, Polyp of Colon, Recurrent Colon Adenoma
Conditions
Brief summary
The EndoRotor® is intended for use (USA labeling) in endoscopic procedures by a trained gastroenterologist to resect and remove tissue, not intended for biopsy, of the gastrointestinal (GI) system including post-endoscopic mucosal resection (EMR) tissue persistence with a scarred base and residual tissue from the peripheral margins following EMR. In this trial investigators will conduct a post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Detailed description
Although the majority of polyps are non-malignant, it is known that the risk of malignancy increases with polyp size, with polyps \< 10 mm having \< 1% risk of cancer, polyps of 10 mm having a 10% risk of cancer and polyps of 20 mm having a greater than 10% risk of cancer. It is also understood that a polyp of \< 1 cm takes approximately 10 years to transform into invasive colorectal carcinoma. Therefore, adenomas greater than 5 mm are normally treated. Polyps with tethered bases resulting from scarring are often the most challenging to resect endoscopically. The scarring can be caused by previous attempts at resection, previous deep biopsies, or tattoos placed too closely. These polyps often do not lift and can be impossible to snare even when stiff snares are used. Endoscopic submucosal dissection (ESD) and knife-assisted resection (KAR) are techniques that have been shown effective in the management of scarred polyps, however these techniques have not been widely adopted in the West. Argon plasma coagulation has been more commonly used to ablate adenomatous tissue in scarred polyps but this technique does not allow for the histological assessment of the scarred polyp and is less effective than ESD. The EndoRotor provides a technique whereby the lesion can be effectively removed without adjunct procedures with collection of tissue for histological assessment.
Interventions
DEVICEEndoRotor Resection
The EndoRotor® is a powered cutting cannula for the removal of alimentary tract mucosa. Cutting is performed by aspirating tissue into a rotating cutting window. The resected tissue is immediately aspirated away from the resection site and collected in the EndoRotor Specimen Trap. The tissue can then be sent for pathological examination using standard methods. The system consists of a power console, foot control, specimen trap with pre-loaded filter and the applied part, which is the single-use catheter.
Sponsors
Interscope, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Post-market, prospective, non-randomized, multi-center study for the treatment of subjects with the need for resection of recurrent flat or sessile colorectal lesions where EndoRotor is the primary resection modality of persistent adenoma with a scarred base.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged ≥18 to ≤85 years. 2. At least one recurrent flat or sessile colorectal lesion measuring up to 6 cm in diameter and/or length. 3. Presence of recurrent flat or sessile lesion where the EndoRotor may be used to resect recurrent neoplasia. 4. Favorable anatomy that allows the investigator to access the lesion. 5. Subject is able and willing to comply with site standard medical follow-up, including the 90-day follow-up visit. 6. Subject has been informed of the nature of the study, agrees to participate and has signed the consent form.
Exclusion criteria
1. Inability to give informed consent. 2. Subject age is \<18 years of age or \>85 years of age. 3. Presence of a lesion that represents cancer or has a high chance of harboring submucosal invasive cancer. 4. Presence of synchronous lesions intended for resection that would require use of a concomitant resection modality 5. Medical reasons the procedure cannot be performed (i.e. labile blood pressure, anticoagulation laboratory levels that are too high and risk excessive bleeding, systemic infection, etc.) 6. Active antiplatelet therapy (Plavix , 325mg aspirin therapy) - patient off treatment for \< 1 week. 7. Inability to undergo a procedure under propofol sedation or General Anesthesia. 8. Female patients who are known to be pregnant. 9. Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g., severe chronic obstructive pulmonary disease, hepatic failure, cardiac disease, autoimmune disorders or conditions of severe immunosuppression). 10. Any clinical evidence that the investigator feels would place the subject at increased risk with the deployment of the device. 11. Subject is participating in another study of a device, medication, biologic, or other agent within 90 days and could, in the opinion of the investigator, impact the results of this study. 12. Subject has other medical, social or psychological problems that in the opinion of the investigator would preclude them from receiving this treatment and the procedures and participating in evaluations pre- and post-treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. | Index Procedure through 90 Day Post Procedure Follow-up Visit |
| Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Index Procedure through 90 Day Post Procedure Follow-up Visit |
Secondary
| Measure | Time frame |
|---|---|
| Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. | 90-day follow-up visit |
| Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. | Index Procedure |
| Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit. | 90-day follow-up visit |
| Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). | 90-day follow-up visit |
Countries
France, Germany, Italy, United States
Participant flow
Recruitment details
Participants were recruited at 12 centers in the US and Europe. First participant was enrolled in the study on January 25, 2018 and the last participant was enrolled in the study on June 24, 2020. Of the 80 patients screened for this study, 66 were enrolled and treated with EndoRotor.
Pre-assignment details
The study was over-enrolled. The protocol required 60 subjects; however, 66 subjects were enrolled and treated of which 62 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| EndoRotor Resection Arm All participants enrolled in this study will undergo treatment with the EndoRotor during colonoscopy for endoscopic mucosal resection in the colon to resect and remove tissue, not intended for biopsy, of the gastrointestinal system including post-endoscopic endoscopic mucosal resection of tissue persistence with a scarred base and residual tissue from peripheral margins following endoscopic mucosal resection.
EndoRotor Resection: To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | PI left center and never scheduled 90 day follow-up visit. | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | EndoRotor Resection Arm |
|---|---|
| Age, Continuous | 69 Years STANDARD_DEVIATION 9 |
| Diastolic Blood Pressure | 76.1 mmHg STANDARD_DEVIATION 11.6 |
| Height | 168.2 cm STANDARD_DEVIATION 10 |
| Race/Ethnicity, Customized African/Black | 1 Participants |
| Race/Ethnicity, Customized Caucasian/White | 49 Participants |
| Race/Ethnicity, Customized Not Disclosed | 16 Participants |
| Sex: Female, Male Female | 39 Participants |
| Sex: Female, Male Male | 27 Participants |
| Systolic Blood Pressure | 135.6 mmHg STANDARD_DEVIATION 25.2 |
| Weight | 76.1 kg STANDARD_DEVIATION 17.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 66 |
| other Total, other adverse events | 6 / 66 |
| serious Total, serious adverse events | 7 / 66 |
Outcome results
Primary
Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit.
Time frame: Index Procedure through 90 Day Post Procedure Follow-up Visit
Population: Primary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Resection Arm | Primary Effectiveness Endpoint Defined as the Ability of the EndoRotor to Resect Lesions Without Concomitant Use of Other Resection Modalities and With no Device-related Serious Adverse Events Through the 90 Day Post Procedure Follow-up Visit. | 45 Participants |
Primary
Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit.
Time frame: Index Procedure through 90 Day Post Procedure Follow-up Visit
Population: The safety analysis will be completed on all subjects who were treated with the EndoRotor device.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EndoRotor Resection Arm | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Total number of serious adverse events in Intent to Treat Population. | 5 Serious Adverse Events |
| EndoRotor Resection Arm | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Delayed Rectal Bleed both mild Relation EndoRotor: probable/possible Relation Proc: Both probable | 2 Serious Adverse Events |
| EndoRotor Resection Arm | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Mucosal Laceration Severe Relation to EndoRotor: Unlikely Relation to Procedure: Possible | 1 Serious Adverse Events |
| EndoRotor Resection Arm | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | Single Arterial Bleed Severe Relation to EndoRotor: Not related Relation to Proc. Not related | 1 Serious Adverse Events |
| EndoRotor Resection Arm | Primary Safety Analysis Defined as the Occurrence of Serious Adverse Events Related to the EndoRotor Device as Measured From the Index Procedure Through the 90 Day Post Procedure Follow-up Visit. | General Infection Moderate Relation to EndoRotor: Not related Relation to Proc. Not related | 1 Serious Adverse Events |
Secondary
Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure.
Time frame: Index Procedure
Population: Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Resection Arm | Efficacy Defined as the Number of Participants Where EndoRotor Was Able to Resect the Entire Lesion in a Single Procedure. | 45 Participants |
Secondary
Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered).
Time frame: 90-day follow-up visit
Population: Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| EndoRotor Resection Arm | Histologic Assessment Defined as the the Diagnostic Value of the Specimens Collected in the EndoRotor Specimen Trap (Could a Diagnosis be Rendered). | 45 Specimens |
Secondary
Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure.
Time frame: 90-day follow-up visit
Population: Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Resection Arm | Post-resection Stenosis Defined as the Occurrence of Colon Stenosis Following the Index Procedure. | 0 Participants |
Secondary
Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit.
Time frame: 90-day follow-up visit
Population: Secondary endpoint analysis will be completed on the per protocol population which consists of subjects who had complete lesion resection with the EndoRotor alone without any adjunctive modality resection, did not have inclusion/exclusion protocol deviations, and completed the 90 day follow-up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EndoRotor Resection Arm | Rate of Disease Persistence Defined as Remnant Disease at the Location of the Index Resection as Determined Endoscopically by the Investigator at the 90 Day Follow-up Visit. | 21 Participants |