NCT07490080

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2026

Completed
Last Updated

March 24, 2026

Status Verified

March 1, 2026

Enrollment Period

1.2 years

First QC Date

March 18, 2026

Last Update Submit

March 18, 2026

Conditions

Anastomosis, Leaking

Outcome Measures

Primary Outcomes (1)

  • Incidence of anastomotic leak

    (Grade B, C according to the International Study Group of Rectal Cancer)

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FN HK

Hradec Králové, Czechia

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2026

First Posted

March 24, 2026

Study Start

October 23, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

March 24, 2026

Record last verified: 2026-03

Locations

CZ(1)