SafeHeal Diverting Ileostomy Pivotal Study
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:
🦠 Colorectal Cancer 🦠 Stoma Ileostomy
🗓️ Study Start (Actual) 1 January 2024
🗓️ Primary Completion (Estimated) 1 December 2025
✅ Study Completion (Estimated) 1 December 2025
👥 Enrollment (Estimated) 196
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Worcester, Massachusetts, United States
📍 Brooklyn, New York, United States
📍 New York, New York, United States

📋 Eligibility Criteria

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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 November 2023
  • First Submitted that Met QC Criteria 21 November 2023
  • First Posted 30 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 6 March 2024
  • Last Update Posted 8 March 2024
  • Last Verified March 2024