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SafeHeal Anastomosis Feasibility Evaluation (SAFE)-2023 Study

NCT06540807 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-20

Study results available
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Summary

A feasibility study to assess the early safety and effectiveness of the Colovac 2 device in providing temporary protection of the anastomosis in patients undergoing low anterior resection for colon cancer.

Conditions

Interventions

DEVICE

Colovac Colorectal Anastomosis Protection Device

A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)

PROCEDURE

Stoma creation

Diverting loop ileostomy

Sponsors & Collaborators

  • SafeHeal Inc

    lead INDUSTRY

Principal Investigators

  • Okiljon Rahimov, MD · Republican Specialized Scientific and Practical Medical Center of Oncology and Radiology MoH of RUz

  • Narxodja Sametdinov, MD · Akfa Medline LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-03-06
Completion
2025-12-26
FDA Device
Yes

Countries

  • Uzbekistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06540807 on ClinicalTrials.gov