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

NCT ID: NCT05010850

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2024-01-19

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.

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.

Conditions

Colorectal Cancer; Rectal Cancer; Rectal Tumor; Rectal/Anal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Colovac

Patients receive Colovac during colorectal surgery

Group Type: EXPERIMENTAL

Colovac

Intervention Type: 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)

Standard of Care

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

Group Type: ACTIVE_COMPARATOR

Stoma Creation

Intervention Type: PROCEDURE

Protective ileostomy

Interventions

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)

Intervention Type: DEVICE

Stoma Creation

Protective ileostomy

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SafeHeal Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia Sylla, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Jeremie Lefevre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hopital Saint Antoine

Locations

Kaiser Permanente - Los Angeles

Los Angeles, California, United States

USC Keck Hospital

Los Angeles, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Tampa General Hospital

Tampa, Florida, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Maimonides Medical Center

Brooklyn, New York, United States

Mount Sinai Hospital

New York, New York, United States

Lenox Hill Hospital

New York, New York, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Universitair Ziekenhuis Antwerpen

Edegem, Antwerp, Belgium

CHU de Besancon

Besançon, , France

ICM Val d'Aurelle

Montpellier, , France

Hopital Saint-Louis

Paris, , France

CHU Rouen Normandie

Rouen, , France

Hôpital Saint Antoine Paris

Paris, Île-de-France Region, France

Countries

United States; Belgium; France

References

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.

Reference Type: DERIVED

PMID: 38750621 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SAFE-2

Identifier Type: -

Identifier Source: org_study_id