Clinical trial · Interventional
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge
NCT02046278CI-TRIAL-00023707completedN/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 Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.
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
- Control arm - Standard of Care
- description
- The anastomosis will be created using Standard of Care only
- type
- EXPERIMENTAL
- label
- Device arm - Standard of Care + LifeSeal™ Kit
- description
- The anastomosis will be created using SOC + LifeSeal™ Kit
- interventionNames
- Device: LifeSeal™ Kit
Primary outcomes (1)
- measure
- Assessment of the overall Subject safety by incidence of pre specified procedure related Adverse Events.
- timeFrame
- Up to 15 weeks
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subject, or authorized representative, signed a written Informed Consent Form 2. Subject is 18 years or older 3. Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge. 4. If female - not be of child bearing potential, or be using acceptable contraception methods. 5. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor. Exclusion Criteria: 1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen 2. Subject participating in any other study involving an investigational (unapproved) drug or device. 3. Subject with a BMI higher than 40 4. Female Subject states that she is pregnant or breast feeding 5. Subject with ASA status higher than 3 6. Avastin use within 30 days prior to surgery 7. Subject who underwent a prior pelvic anastomosis 8. Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
References
Publications (0)
Data not yet available
No reference posted for this study.