Clinical trial NCT05010850: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
Official title: SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study: A Study to Evaluate the Safety and Effectiveness of the Colovac Colorectal Anastomosis Protection Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Rectal Cancer
Rectal Tumor
Rectal/Anal
Keywords: anastomosis
leak
colorectal
ileostomy
Lead sponsor: SafeHeal Inc
Sponsor class: INDUSTRY
First posted: 2021-08-18
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized trial to assess the safety and effectiveness of the Colovac in providing temporary protection of the anastomosis in subjects undergoing lower anterior resection for colorectal cancer.

Detailed description: A primary diverting stoma is widely used by surgeons in order to bypass the low rectal anastomosis and reduce morbidity associated with anastomotic leaks. Typically, a stoma is created for all high-risk patients which means that many patients are exposed to potentially serious complications associated with the stoma itself without any clinical benefit.

Colovac is a local, temporary, minimally invasive bypass device that provides protection of the anastomosis and safely postpones stoma creation for 10 days after surgery. By postponing stoma creation for 10 days, Colovac is designed to avoid stoma creation in all patients except those patients whose anastomoses have not healed by 10 days after surgery, allowing the others to return to normal activity more quickly and safely.

Eligibility criteria: Inclusion Criteria:

1. Adult patients (greater than 18 years of age)
2. Eligible to undergo open or minimally invasive sphincter-preserving lower anterior resection (anastomosis within 10 cm of the anal verge) with planned diverting loop ileostomy for malignant indication, assessed by a multi-disciplinary team.
3. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
4. Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

1. History of left colitis
2. Known allergy to nickel or other components of the Colovac kit
3. Pregnant or nursing female subject
4. Concomitant major surgical procedure in combination with Colorectal resection (e.g.. 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. COVID-19 positive (active infection) if test required by hospital
   2. Immunodeficiency (CD4+ count \< 500 mm3)
   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, 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
   9. Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
6. The subject is currently participating in another investigational drug or device study
7. Occurrence of any of the following during the colorectal surgery:

   1. Blood loss (\>750 cc)
   2. Blood transfusion
   3. Any new sign of ischemia
   4. Positive air leak test
   5. Inadequate bowel preparation
   6. Anastomosis location greater than 10 cm from the anal verge
   7. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Primary outcomes:
measure: Avoidance of ostomy
timeFrame: 12 Months
measure: Safety Major Complications
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente - Los Angeles
state: California
city: Los Angeles
country: United States
facility: USC Keck Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
state: Antwerp
city: Paris
country: France
facility: Hôpital Saint Antoine Paris
state: Ile-de-France
city: Besançon
country: France
facility: CHU de Besancon
city: Montpellier
country: France
facility: ICM Val d'Aurelle
city: Paris
country: France
facility: Hopital Saint-Louis
city: Rouen
country: France
facility: CHU Rouen Normandie
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Patricia Sylla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Saint Antoine
name: Jeremie Lefevre, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: