Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
Public ClinicalTrials.gov record NCT02907385. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored. RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis. In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge. STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery. SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.
Study identification
- NCT ID
- NCT02907385
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 736 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2016
- Primary completion
- Feb 28, 2018
- Completion
- Aug 31, 2020
- Last update posted
- Mar 29, 2018
2016 – 2020
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern CA | Los Angeles | California | — | — |
| Stanford University | Stanford | California | — | — |
| Florida Hospital | Florida City | Florida | — | — |
| Tampa General Hospital | Tampa | Florida | — | — |
| Cleveland Clinic Florida | Weston | Florida | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| Franciscan | Indianapolis | Indiana | — | — |
| Indiana University | Indianapolis | Indiana | — | — |
| Ochsner Clinic Foundation | Jefferson | Louisiana | — | — |
| Johns Hopkins Hospital | Baltimore | Maryland | — | — |
| Medical University SC (MUSC) | Worcester | Massachusetts | — | — |
| University of Massachusetts | Worcester | Massachusetts | — | — |
| Spectrum Health | Grand Rapids | Michigan | — | — |
| Washington University | St Louis | Missouri | — | — |
| Albany medical center | Albany | New York | — | — |
| New York University | New York | New York | — | — |
| Cleveland Clinic | Cleveland | Ohio | — | — |
| University Hospital Cleveland Medical Center | Cleveland | Ohio | — | — |
| Penn state university | State College | Pennsylvania | — | — |
| Duke University | Durham | South Carolina | — | — |
| University of Vermont | Burlington | Vermont | — | — |
| University of Virginia | Charlottesville | Virginia | — | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02907385, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 29, 2018 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02907385 live on ClinicalTrials.gov.