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.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07490080

Enrollment

Registered

2026-03-24

Start date

2024-10-23

Completion date

2025-12-30

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomosis, Leaking

Brief summary

A two-phase, multicenter, open-label, "first-in-human" prospective study evaluating the product's safety and efficacy in a pivotal phase.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence of anastomotic leak	30 days	(Grade B, C according to the International Study Group of Rectal Cancer)

Countries

Czechia

Outcome results