Safe Anastomosis Feasibility Study

SafeHeal Inc27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Anastomosis

Interventions

ColovacDEVICE

A removable, temporary intraluminal bypass device designed to safely postpone the creation of a protective stoma until 10 days after surgery for only patients who need it (do not have a healed anastomosis)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

UZA

Antwerp, Belgium

Centre Hospitalier Universitaire St Pierre

Brussels, Belgium

CHU Lille

Lille, France

ICM Montpellier

Montpellier, France

Outcomes

Primary Outcomes

To measure the incidence of serious adverse events related to using the device

The primary endpoint will be a measurement of SAEs probably related or causaly related to the use of the investigational device, to the index surgery in this clinical trial.

Time frame: 3 months

Secondary Outcomes

To measure the number of participants with evidence of absence of feces between the sheath and the colonic wall before device retrieval

Rate of patients with evidence of absence of feces between the sheath and the colonic wall before device retrieval at 10 days:

Time frame: 10 days

To measure the rate of ostomy avoidance

To measure the number of participants where ostomy was avoided

Time frame: 3 months

To evaluate the occurrence of clinical anastomotic leakage

Rate of clinical leakage, defined as number of clinically manifest insufficiency of the anastomosis leading to a clinical state requiring treatment: * Rate of patients with radiological evidence of anastomotic leakage if the patient is clinically symptomatic * Prior to retrieval of the Colovac+ Device, a systematic contrast radiographic imaging will be performed using a radio-opaque contrast agent injected trans-anally, in order to check for any potential anastomotic complication.

Time frame: 3 months

To measure on a scale of 1 to 5 rated by the surgeon the ease of device introduction, positioning and endoscopic retrieval

* Ease of device introduction and positioning will be rated by the surgeon on a scale from 1 to 5 (1 being very easy and 5 being impossible) * Ease of endoscopic retrieval of the device will be rated by the endoscopist on a scale from 1 to 5 (1 being very easy and 5 being impossible)

Time frame: 10 days

Data from ClinicalTrials.gov

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