Clinical trial NCT06152276: SafeHeal Diverting Ileostomy Pivotal Study
Official title: SafeHeal Diverting Ileostomy Pivotal Study (SH-SOC23)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Colorectal Cancer
Stoma Ileostomy
Lead sponsor: SafeHeal Inc
Sponsor class: INDUSTRY
First posted: 2023-11-30
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal cancer undergoing low anterior resection following by a diverting loop ileostomy.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early anastomotic complications
timeFrame: 9 months
measure: Overall major complications
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
Study officials:
References: