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

SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device

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.

Study Overview

• Status: Terminated
• Conditions: Colorectal Cancer; Rectal Cancer; Rectal Tumor; Rectal/Anal
• Intervention / Treatment: Device: Colovac; Procedure: Stoma Creation

Detailed Description

A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

Colovac is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Universitair Ziekenhuis Antwerpen
• France
  • Besançon, France, 25030
    • CHU de Besançon
  • Montpellier, France, 34090
    • ICM Val d'Aurelle
  • Paris, France, 75010
    • Hôpital Saint-Louis
  • Rouen, France, 76031
    • CHU Rouen Normandie
  • Ile-de-France
    • Paris, Ile-de-France, France, 75571
      • Hôpital Saint Antoine Paris
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente - Los Angeles
    • Los Angeles, California, United States, 90033
      • USC Keck Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adult patients (greater than 18 years of age)
2. 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.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
4. Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

1. History of left colitis
2. Known allergy to nickel or other components of the Colovac kit
3. Pregnant or nursing female subject
4. Concomitant major surgical procedure in combination with Colorectal resection (e.g.. hepatectomy)

5. 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:

   1. COVID-19 positive (active infection) if test required by hospital
   2. Immunodeficiency (CD4+ count < 500 mm3)
   3. Systemic steroid therapy within the past 6 months
   4. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
   5. 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
   6. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
   7. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
   8. Severe Malnutrition defined as ≥ 10% weight loss within 3 months prior to enrollment
   9. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
6. The subject is currently participating in another investigational drug or device study

7. Occurrence of any of the following during the colorectal surgery:

   1. Blood loss (>750 cc)
   2. Blood transfusion
   3. Any new sign of ischemia
   4. Positive air leak test
   5. Inadequate bowel preparation
   6. Anastomosis location greater than 10 cm from the anal verge
   7. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colovac; Patients receive Colovac during colorectal surgery	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)
Active Comparator: Standard of Care; Patients receive the standard of care, a protective stoma, during colorectal surgery	Procedure: Stoma Creation; Protective ileostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Major Complications	Rate of subjects with major complications	12 Months
Avoidance of Ostomy	Reduction in stoma creation rate	12 Months

Collaborators and Investigators

• Sponsor: SafeHeal Inc
• Investigators: Principal Investigator: Patricia Sylla, MD, Mount Sinai Hospital; Principal Investigator: Jeremie Lefevre, MD, PhD, Hôpital Saint Antoine

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): January 19, 2024
• Study Completion (Actual): January 19, 2024

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ileostomy; colorectal; anastomosis; leak
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: SAFE-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes