SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study (SAFE-2)

  • STATUS
    Recruiting
  • End date
    Oct 16, 2023
  • participants needed
    302
  • sponsor
    SafeHeal Inc
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Updated on 16 June 2022
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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.

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.

Details
Condition Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal
Treatment COLOVAC, Stoma Creation, Stoma Creation
Clinical Study IdentifierNCT05010850
SponsorSafeHeal Inc
Last Modified on16 June 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Adult patients (greater than 18 years of age)
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
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
Willing to comply with protocol-specific treatment and study visits and to sign a written Informed Consent Form

Exclusion Criteria

History of left colitis
Known allergy to nickel or other components of the Colovac kit
Pregnant or nursing female subject
Concomitant major surgical procedure in combination with Colorectal resection (e.g.. hepatectomy)
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
COVID-19 positive (active infection) based on test within 48 hours prior to surgery
Immunodeficiency (CD4+ count < 500 mm3)
Systemic steroid therapy within the past 6 months
Systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery
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
Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel, carcinomatosis
Fecal incontinence, involvement of sphincter by the neoplastic disease or evidence of extensive local disease in the pelvis seen on pre-operative imaging
Severe Malnutrition defined as ≥ 10% weight loss within 3 months prior to enrollment
The subject is currently participating in another investigational drug or device study
Occurrence of any of the following during the colorectal surgery
Blood loss (>750 cc)
Blood transfusion
Any new sign of ischemia
Positive air leak test - requiring re intervention on the anastomosis
Inadequate bowel preparation
Anastomosis location greater than 10 cm from the anal verge
Other intra-operative risks that preclude the subject from undergoing the procedure with the investigational device
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