SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Stoma Ileostomy
• Intervention / Treatment: Other: Diverting loop ileostomy

Detailed Description

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.

The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.

• Study Type: Observational
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • UZA
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium, 3000
      • UZ Leuven
• France
  • Paris, France, 75010
    • Hopital Saint-Louis
  • Paris, France, 75012
    • Hôpital Saint Antoine Paris
  • New Aquitaine
    • Bourdeaux, New Aquitaine, France, 33000
      • Bordeaux Colorectal Institute
  • Normandy
    • Rouen, Normandy, France, 76031
      • Chu du Rouen
• Italy
  • Lombardi
    • Rozzano, Lombardi, Italy, 20089
      • Humanitas Research Hospital
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90033
      • Keck Medicine of USC
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente - Los Angeles
    • Los Angeles, California, United States, 90033
      • USC Keck Hospital
  • Florida
    • Miami, Florida, United States, 33146
      • University of Miami
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center
    • Worcester, Massachusetts, United States, 01605
      • UMass Memorial Medical Center
  • 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
    • New York, New York, United States, 10065
      • New York Presbyterian Cornell
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

Preoperative

1. History of left colitis
2. Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
3. Pregnant or nursing female subject
4. Concomitant major surgical procedure in combination with Colorectal resection (i.e., 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. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
   2. Immunodeficiency (CD4+ count < 500 CU MM)
   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, or 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.

6. The subject is currently participating in another investigational drug or device study

   Intraoperatively:

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

   1. Blood loss (>750 cc)
   2. Blood transfusion
   3. Any new sign of bowel ischemia
   4. Positive air leak test
   5. Inadequate bowel preparation
   6. Anastomosis location greater than 10 cm from the anal verge
   7. Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care Arm; Diverting loop ileostomy following low anterior resection of colorectal cancer	Other: Diverting loop ileostomy; Diverting loop ileostomy following low anterior resection of colorectal cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early anastomotic complications	Early anastomotic complications	9 months
Overall major complications	Major complications	9 months

Collaborators and Investigators

• Sponsor: SafeHeal Inc
• Investigators: Principal Investigator: Patricia Sylla, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): January 30, 2026
• Study Completion (Actual): January 30, 2026

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 30, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SH-SOC23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data is confidential and only available upon a reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No