SafeHeal Diverting Ileostomy Pivotal Study

NCT06152276 | Completed DMC

• 1 other identifier: SH-SOC23
• Study Type: observational
• Target: 132
• Locations: 4 countries
• Sites: 22

Brief Summary

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard of care cancer treatment.

Conditions

Stoma Ileostomy; Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Early anastomotic complications

  Early anastomotic complications

  9 months

• Overall major complications

  Major complications

  9 months

Study Arms (1)

Standard of Care Arm

Diverting loop ileostomy following low anterior resection of colorectal cancer

Other: Diverting loop ileostomy

Interventions

Diverting loop ileostomy OTHER

Diverting loop ileostomy following low anterior resection of colorectal cancer

Standard of Care Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal cancer undergoing low anterior resection following by a diverting loop ileostomy.

You may qualify if:

• Adult patients (18 years of age or older)
• Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
• Willingness to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

You may not qualify if:

• Preoperative
• History of left colitis
• Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
• Pregnant or nursing female subject
• Concomitant major surgical procedure in combination with Colorectal resection (i.e., 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:
• Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
• Immunodeficiency (CD4+ count \< 500 CU MM)
• 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, or 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.
• The subject is currently participating in another investigational drug or device study

Sponsors & Collaborators

• SafeHeal Inc: lead

Study Sites (22)

Kaiser Permanente - Los Angeles

Los Angeles, California, 90027, United States

Location

Keck Medicine of USC

Los Angeles, California, 90033, United States

Location

USC Keck Hospital

Los Angeles, California, 90033, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

New York Presbyterian Cornell

New York, New York, 10065, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Novant Health

Winston-Salem, North Carolina, 27103, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

UZA

Edegem, Antwerp, 2650, Belgium

Location

UZ Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Bordeaux Colorectal Institute

Bourdeaux, New Aquitaine, 33000, France

Location

Chu du Rouen

Rouen, Normandy, 76031, France

Location

Hopital Saint-Louis

Paris, 75010, France

Location

Hôpital Saint Antoine Paris

Paris, 75012, France

Location

Humanitas Research Hospital

Rozzano, Lombardi, 20089, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Patricia Sylla, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 30, 2023
• Study Start: January 1, 2024
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); IT (1); BE (2); US (15)