Clinical trial NCT05180565: Safe Anastomosis Feasibility Study
Official title: Safe Anastomosis Feasibility Study: a Study to Investigate the Efficacy, Mechanism of Action and Safety of the Colovac+ Colorectal Anastomosis Protection Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Anastomosis
Keywords: anastomosis
Lead sponsor: SafeHeal Inc
Sponsor class: INDUSTRY
First posted: 2022-01-06
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A clinical trial to assess the efficacy, mechanism of action and safety of the Colovac+ Colorectal Anastomosis Protection Device 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:

* 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.
* Willingness to comply with Clinical Investigation Plan-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria:

- Preoperatively :

1. Patient with inflammatory bowel disease
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 (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 Clinical Investigation Plan described procedures or interfere with the interpretation of study results. including, but not limited to:

   1. COVID-19 positive (active infection) based on test within 72 hours prior to surgery
   2. Metastatic disease - unless previously treated with chemotherapy and resection, and the benefit of exposure to the Colovac device is greater than the risk 1
   3. Immunodeficiency (CD4+ count \< 500 CU MM)
   4. Systemic steroid therapy within the past 6 months
   5. Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
   6. 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
   7. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
   8. Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
   9. 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. Anastomosis placement at more than 10cm from anal margin
8. 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 - requiring re intervention on the anastomosis
   5. Inadequate bowel preparation
   6. Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device

Primary outcomes:
measure: To measure the incidence of serious adverse events related to using the device
timeFrame: 3 months
Secondary outcomes:
measure: To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval
timeFrame: 10 days
measure: To measure the rate of ostomy avoidance
timeFrame: 3 months
measure: To evaluate the occurrence of clinical anastomotic leakage
timeFrame: 3 months
measure: To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval
timeFrame: 10 days
measure: To evaluate the clinically significant migration rate
timeFrame: 10 days
measure: To evaluate the integrity above the anchoring site during the device retrieval using endoscopy.
timeFrame: 10 days
measure: To evaluate the integrity of the anchoring site during the device retrieval using endoscopy.
timeFrame: 10 days
measure: To evaluate the integrity of the anastomosis before the device retrieval using fluoroscopy
timeFrame: 10 days
measure: To evaluate the integrity of the anastomosis after the device retrieval using fluoroscopy
timeFrame: 10 days
measure: To measure the average procedure time
timeFrame: 1 day
measure: To measure the patient tolerability of the device using a patient questionnaire
timeFrame: 10 days
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: UZA
city: Brussels
country: Belgium
facility: Centre Hospitalier Universitaire St Pierre
city: Lille
country: France
facility: CHU Lille
city: Montpellier
country: France
facility: ICM Montpellier
city: Paris
country: France
facility: Hôpital Saint Louis
city: Paris
country: France
facility: Hôpital Saint Antoine Paris
city: Strasbourg
country: France
facility: CHRU Strasbourg
Study officials:
affiliation: Hôpital Saint Antoine Paris
name: Jérémie Lefevre
role: PRINCIPAL_INVESTIGATOR
References: