Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis

March 18, 2026 updated by: Contipro Pharma a.s.

Multi-centre, Open-label, First-in-man Study With Dehisgel Used in Adult Patients Undergoing Colorectal Anastomosis Due to Rectal Cancer.

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

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Hradec Králové, Czechia
        • FN HK

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The patients included in the study underwent elective rectal resection with colorectal anastomosis due to rectal cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Contipro Pharma a.s.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Actual)

December 30, 2025

Study Completion (Actual)

December 30, 2025

Study Registration Dates

First Submitted

March 18, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • PT-DEH-1_02-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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