SafeHeal Diverting Ileostomy Pivotal Study

Completed

Conditions studied: Colorectal Cancer, Stoma Ileostomy

In brief

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.

Key facts

Study ID

NCT06152276

Run by

SafeHeal Inc

People needed

132

Starts

2024-01-01

Expected to finish

2026-01-30

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Intraoperatively:
• Occurrence of any of the following during the colorectal surgery:
• Blood loss (>750 cc)
• Blood transfusion
• Any new sign of bowel ischemia
• Positive air leak test
• Inadequate bowel preparation
• Anastomosis location greater than 10 cm from the anal verge
• Any other surgical complications or intra-operative risks that may place the patient at greater risk from study procedures

Where it is running

• Kaiser Permanente - Los Angeles — Los Angeles, California, United States
• Keck Medicine of USC — Los Angeles, California, United States
• USC Keck Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of Miami — Miami, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Northwestern University — Chicago, Illinois, United States
• Boston Medical Center — Boston, Massachusetts, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• New York Presbyterian Cornell — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• UZA — Edegem, Antwerp, Belgium
• UZ Leuven — Leuven, Flemish Brabant, Belgium
• Bordeaux Colorectal Institute — Bourdeaux, New Aquitaine, France
• Chu du Rouen — Rouen, Normandy, France
• Hopital Saint-Louis — Paris, France
• Hôpital Saint Antoine Paris — Paris, France
• Humanitas Research Hospital — Rozzano, Lombardi, Italy

Full record on ClinicalTrials.gov

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