NCT05010850

Brief 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.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2022

Geographic Reach
3 countries

16 active sites

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

First Submitted

Initial submission to the registry

August 11, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 17, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 3, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2 years

First QC Date

August 11, 2021

Results QC Date

June 3, 2025

Last Update Submit

June 17, 2025

Conditions

Colorectal CancerRectal CancerRectal TumorRectal/Anal

Keywords

anastomosisleakcolorectalileostomy

Outcome Measures

Primary Outcomes (2)

  • Avoidance of Ostomy

    Reduction in stoma creation rate

    12 Months

  • Safety Major Complications

    Rate of subjects with major complications

    12 Months

Study Arms (2)

Colovac

EXPERIMENTAL

Patients receive Colovac during colorectal surgery

Device: Colovac

Standard of Care

ACTIVE COMPARATOR

Patients receive the standard of care, a protective stoma, during colorectal surgery

Procedure: Stoma Creation

Interventions

ColovacDEVICE

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)

Colovac
Stoma CreationPROCEDURE

Protective ileostomy

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (greater than 18 years of age)
  • Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
  • Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

You may not qualify if:

  • History of left colitis
  • Known allergy to nickel or other components of the Colovac kit
  • Pregnant or nursing female subject
  • Concomitant major surgical procedure in combination with Colorectal resection (e.g.. hepatectomy)
  • Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation, impair the ability of the participant to undergo protocol described procedures or interfere with the interpretation of study results. including, but not limited to:
  • COVID-19 positive (active infection) if test required by hospital
  • Immunodeficiency (CD4+ count \< 500 mm3)
  • Systemic steroid therapy within the past 6 months
  • Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
  • Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
  • Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
  • Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
  • Severe Malnutrition defined as ≥ 10% weight loss within 3 months prior to enrollment
  • Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
  • The subject is currently participating in another investigational drug or device study
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Kaiser Permanente - Los Angeles

Los Angeles, California, 90027, United States

Location

USC Keck Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, 2650, Belgium

Location

CHU de Besancon

Besançon, 25030, France

Location

ICM Val d'Aurelle

Montpellier, 34090, France

Location

Hopital Saint-Louis

Paris, 75010, France

Location

CHU Rouen Normandie

Rouen, 76031, France

Location

Hôpital Saint Antoine Paris

Paris, Île-de-France Region, 75571, France

Location

Related Publications (1)

  • Hain E, Lefevre JH, Ricardo A, Lee S, Zaghiyan K, McLemore E, Sherwinter D, Rhee R, Wilson M, Martz J, Maykel J, Marks J, Marcet J, Rouanet P, Maggiori L, Komen N, De Hous N, Lakkis Z, Tuech JJ, Attiyeh F, Cotte E, Sylla P. SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device. Colorectal Dis. 2024 Jun;26(6):1271-1284. doi: 10.1111/codi.17012. Epub 2024 May 15.

    PMID: 38750621DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Limitations and Caveats

The SAFE-2 study was voluntarily terminated early by the sponsor due to non-safety reasons. Given the limited sample size of SAFE-2, further studies with larger cohorts are recommended.

Results Point of Contact

Title
Heather Cronin, VP Clinical Affairs
Organization
SafeHeal
hcronin@safeheal.com
5184289593

Study Officials

  • Patricia Sylla, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

  • Jeremie Lefevre, MD, PhD

    Hopital Saint Antoine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2021

First Posted

August 18, 2021

Study Start

January 17, 2022

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

July 3, 2025

Results First Posted

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)FR(5)US(10)