Colectomy; Gynecological; Thoracic
Conditions
Brief summary
This prospective, single-arm, multi-center, evaluation will collect clinical data in a post-market setting. The three types of procedures studied will be colectomy, gynecological, and thoracic. Investigators will perform each procedure using the device in compliance with their standard surgical approach and the ENSEAL X1 instructions for use.
Detailed description
The primary objective of this study is to prospectively generate device specific clinical data related to hemostasis in a post-market setting using the ENSEAL X1 per its instructions for use. There will be no blinding or planned interim analysis in this study.
Interventions
DEVICEENSEAL X1
ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
Sponsors
Ethicon Endo-Surgery
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Elective procedure (colectomy, gynecological, or thoracic) where at least one vessel is planned to be transected by the ENSEAL X1 device per its instructions for use; 2. Willingness to give consent and comply with all study-related evaluations and treatment schedule; and 3. At least 18 years of age.
Exclusion criteria
1. Physical or psychological condition which would impair study participation; or 2. Enrollment in a concurrent clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | Intraoperative, after vessel has been transected | * Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis Grading Assessment for Each Vessel Transection | Intraoperative, after vessel has been transected | * Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
| Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | Intraoperative, after vessel has been transected | * Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
| Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Intraoperative, after vessel has been transected | * Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products). |
Countries
United Kingdom, United States
Participant flow
Pre-assignment details
Planned on 100 enrolled but 101 was enrolled due to timing and study closure.
Participants by arm
| Arm | Count |
|---|---|
| ENSEAL X1 Large Jaw Tissue Sealer Use of the ENSEAL X1 Large Jaw Tissue Sealer | 101 |
| Total | 101 |
Baseline characteristics
| Characteristic | ENSEAL X1 Large Jaw Tissue Sealer |
|---|---|
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 96 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 101 |
| other Total, other adverse events | 43 / 101 |
| serious Total, serious adverse events | 12 / 101 |
Outcome results
Primary
Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1
* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: Intraoperative, after vessel has been transected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Colectomy | Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | 100.0 Percentage of Vessels |
| Gynecological | Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | 94.2 Percentage of Vessels |
| Thoracic | Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | 96.7 Percentage of Vessels |
| Total | Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 | 96.2 Percentage of Vessels |
Secondary
Hemostasis Grading Assessment for Each Vessel Transection
* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: Intraoperative, after vessel has been transected
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Colectomy | Hemostasis Grading Assessment for Each Vessel Transection | Grade 1 | 63 Vessels Transected |
| Colectomy | Hemostasis Grading Assessment for Each Vessel Transection | Grade 2 | 4 Vessels Transected |
| Colectomy | Hemostasis Grading Assessment for Each Vessel Transection | Grade 3 | 1 Vessels Transected |
| Colectomy | Hemostasis Grading Assessment for Each Vessel Transection | Grade 4 | 0 Vessels Transected |
| Gynecological | Hemostasis Grading Assessment for Each Vessel Transection | Grade 2 | 14 Vessels Transected |
| Gynecological | Hemostasis Grading Assessment for Each Vessel Transection | Grade 3 | 7 Vessels Transected |
| Gynecological | Hemostasis Grading Assessment for Each Vessel Transection | Grade 4 | 9 Vessels Transected |
| Gynecological | Hemostasis Grading Assessment for Each Vessel Transection | Grade 1 | 126 Vessels Transected |
| Thoracic | Hemostasis Grading Assessment for Each Vessel Transection | Grade 3 | 3 Vessels Transected |
| Thoracic | Hemostasis Grading Assessment for Each Vessel Transection | Grade 2 | 3 Vessels Transected |
| Thoracic | Hemostasis Grading Assessment for Each Vessel Transection | Grade 4 | 3 Vessels Transected |
| Thoracic | Hemostasis Grading Assessment for Each Vessel Transection | Grade 1 | 81 Vessels Transected |
| Total | Hemostasis Grading Assessment for Each Vessel Transection | Grade 4 | 12 Vessels Transected |
| Total | Hemostasis Grading Assessment for Each Vessel Transection | Grade 2 | 21 Vessels Transected |
| Total | Hemostasis Grading Assessment for Each Vessel Transection | Grade 1 | 270 Vessels Transected |
| Total | Hemostasis Grading Assessment for Each Vessel Transection | Grade 3 | 11 Vessels Transected |
Secondary
Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up
* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: Intraoperative, after vessel has been transected
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Colectomy | Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | 0 Vessels Transected |
| Gynecological | Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | 7 Vessels Transected |
| Thoracic | Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | 1 Vessels Transected |
| Total | Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up | 8 Vessels Transected |
Secondary
Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used
* Grade 1: no bleeding at transection site; * Grade 2: minor bleeding at transection site, no intervention needed; * Grade 3: minor bleeding at transection site, mild intervention needed, use of monopolar device and/or touch-ups with ENSEAL X1; * Grade 4: significant bleeding (e.g., pulsatile blood flow, venous pooling) requiring intervention such as extensive coagulation or ligation with additional hemostatic products (e.g., hemoclips, staples, sutures, fibrin sealants, other advanced energy products).
Time frame: Intraoperative, after vessel has been transected
Population: There were no Grade 4 vessels seen in the colectomy procedures.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery and vein (suture) | 2 Vessels Transected |
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery (suture) | 2 Vessels Transected |
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right uterine artery (suture) | 4 Vessels Transected |
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right ovarian artery (suture) | 1 Vessels Transected |
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Short gastric (suture -1; hemoclip -1) | 0 Vessels Transected |
| Colectomy | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Gastroepiploic (suture) | 0 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Gastroepiploic (suture) | 1 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery and vein (suture) | 0 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right ovarian artery (suture) | 0 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Short gastric (suture -1; hemoclip -1) | 2 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery (suture) | 0 Vessels Transected |
| Gynecological | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right uterine artery (suture) | 0 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery (suture) | 2 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right uterine artery (suture) | 4 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Gastroepiploic (suture) | 1 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Right ovarian artery (suture) | 1 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Left uterine artery and vein (suture) | 2 Vessels Transected |
| Thoracic | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used | Short gastric (suture -1; hemoclip -1) | 2 Vessels Transected |