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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colectomy/Gynecological/Thoracic | Experimental | Any colectomy/gynecological/thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ENSEAL X1 | Device | ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 |
| Intraoperative, after vessel has been transected |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostasis Grading Assessment for Each Vessel Transection |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce Robb, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| Queen Elizabeth Hospital |
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Planned on 100 enrolled but 101 was enrolled due to timing and study closure.
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| ID | Title | Description |
|---|---|---|
| FG000 | Colectomy | Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
| FG001 | Gynecological | Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
| FG002 | Thoracic | Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ENSEAL X1 Large Jaw Tissue Sealer | Use of the ENSEAL X1 Large Jaw Tissue Sealer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Vessels Where Hemostasis (<= Grade 3) is Achieved Using ENSEAL X1 |
| Posted | Number | 95% Confidence Interval | Percentage of Vessels | Intraoperative, after vessel has been transected | Vessels Transected | Vessels Transected |
|
4 Weeks Post Procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ENSEAL X1 Large Jaw Tissue Sealer | Use of the ENSEAL X1 Large Jaw Tissue Sealer |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus paralytic | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jason Waggoner, PhD | Ethicon Endo-Surgery | +1 513.337.8310 | jwaggon1@its.jnj.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2019 | Jul 22, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2019 | Jul 22, 2020 | SAP_001.pdf |
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| Intraoperative, after vessel has been transected |
| Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up |
| Intraoperative, after vessel has been transected |
| Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used |
| Intraoperative, after vessel has been transected |
| Birmingham |
| B15 2TH |
| United Kingdom |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| Western General Hospital | Edinburgh | EH4 2XU | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G4 0SF | United Kingdom |
| Yeovil District Hospital | Yeovil | BA21 4AT | United Kingdom |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Gynecological |
Any gynecological procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
| OG002 | Thoracic | Any thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
| OG003 | Total | Any colectomy, gynecological or thoracic procedure where ENSEAL X1 is used for transecting and sealing vessels according to instructions for use. |
|
|
| Secondary | Hemostasis Grading Assessment for Each Vessel Transection |
| Posted | Count of Units | Vessels Transected | Intraoperative, after vessel has been transected | Vessels Transected | Vessels Transected |
|
|
|
| Secondary | Number of Grade 3 Vessels Needing ENSEAL X1 Touch-up |
| Posted | Number | Vessels Transected | Intraoperative, after vessel has been transected | Grade 3 Vessels | Grade 3 Vessels |
|
|
|
| Secondary | Number of Hemostasis Grade 4 Transections and Hemostatic Interventions Used |
| There were no Grade 4 vessels seen in the colectomy procedures. | Posted | Number | Vessels Transected | Intraoperative, after vessel has been transected | Grade 4 Vessels | Grade 4 Vessels |
|
|
|
| 1 |
| 101 |
| 12 |
| 101 |
| 43 |
| 101 |
| Empyema | Infections and infestations | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Suture related complication | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Blood creatinine increased | Investigations | Systematic Assessment |
|
| Blood potassium increased | Investigations | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Pain | General disorders | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Vessels Transected |
|
| Grade 2 |
|
| Grade 3 |
|
| Grade 4 |
|
| Grade 3 Vessels |
|
|
| Right uterine artery (suture) |
|
| Right ovarian artery (suture) |
|
| Short gastric (suture -1; hemoclip -1) |
|
| Gastroepiploic (suture) |
|