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SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study

NCT05010850 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-07-03

Study results available
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Summary

A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

Conditions

Interventions

DEVICE

Colovac

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

Protective ileostomy

Sponsors & Collaborators

  • SafeHeal Inc

    lead INDUSTRY

Principal Investigators

  • Patricia Sylla, MD · MOUNT SINAI HOSPITAL

  • Jeremie Lefevre, MD, PhD · Hopital Saint Antoine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2024-01-19
Completion
2024-01-19
FDA Device
Yes

Countries

  • United States
  • Belgium
  • France

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 NCT05010850 on ClinicalTrials.gov