Clinical trial · Observational
Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis
Multi-centre, Open-label, First-in-man Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis Due to Rectal Cancer.
NCT07490080CI-TRIAL-00106370terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): safety was ok, but efficacy was considered too low - it was decided not to continue woth this study design
Summary
Brief summary (as posted)
A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.
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 |
|---|---|---|---|
| Anastomosis, Leaking | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of anastomotic leak
- timeFrame
- 30 days
- description
- (Grade B, C according to the International Study Group of Rectal Cancer)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Age ≥ 18 years * Patients with histologically confirmed rectal adenocarcinoma (\< 15 cm from the anal margin) following rectal resection with colorectal anastomosis * Patients with or without neoadjuvant therapy * Patients willing and able to provide written informed consent * Patients able to communicate effectively with the investigator in the local language and to understand and comply with the study requirements. Exclusion criteria * Age \< 18 years * Pregnant or breastfeeding women * Patients in the terminal stage of life * Subjects with known hypersensitivity or allergy to any component of the investigational product or to the administered antibiotics * Acute surgery * Preventive ostomy * Other malignancies * Incomplete data
References
Publications (0)
Data not yet available
No reference posted for this study.