Clinical trial · Interventional
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection
NCT01790230CI-TRIAL-00011984completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A preliminary Study in Subjects Undergoing Low Anterior Resection
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LifeSeal™ Kit | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- Standard of Care Arm - subjects treated by routine manner
- type
- EXPERIMENTAL
- label
- LifeSeal™ Kit
- description
- LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment
- interventionNames
- Device: LifeSeal™ Kit
Primary outcomes (1)
- measure
- Assessment of subject's safety by incidence of related Adverse Events
- timeFrame
- Approx. 1 month
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject, or authorized representative, signed a written Informed Consent 2. Subject is at least 18 years of age 3. Subject is scheduled for elective open resection 4. Stapled anastomosis created within 10cm of the anal verge 5. Subject is willing to comply with the follow-up requirements of the study Exclusion Criteria: 1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen 2. Subject has unacceptable baseline hematological results 3. Subject on chronic preoperative treatment with steroids and anticoagulants 4. Subject with elevated liver function tests 5. Subject with abnormal kidney function 6. Subject with a BMI higher than 35 7. Subject participating in any other study for either drug or device which can influence collection of valid data under this study 8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than 1 year 9. Anastomosis was performed differently from what was defined 10. Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the LifeSeal™ 11. Subject has intraoperative bleeding in excess of 500cc 12. Subject has peritoneal carcinomatosis
References
Publications (0)
Data not yet available
No reference posted for this study.