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

Stopped early · Not applicable

Conditions studied: Colorectal Cancer, Rectal Cancer, Rectal Tumor, Rectal/Anal

In brief

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.

Key facts

Study ID

NCT05010850

Run by

SafeHeal Inc

People needed

18

Starts

2022-01-17

Expected to finish

2024-01-19

Last updated by the study team

2025-07-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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) if test required by hospital
• 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
• Stage IV colorectal cancer unless curative intent R0 resection is planned AND there is no associated peritoneal disease
• 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
• 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

Where it is running

• Kaiser Permanente - Los Angeles — Los Angeles, California, United States
• USC Keck Hospital — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Tampa General Hospital — Tampa, Florida, United States
• UMass Memorial Medical Center — Worcester, Massachusetts, United States
• Dartmouth-Hitchcock — Lebanon, New Hampshire, United States
• Maimonides Medical Center — Brooklyn, New York, United States
• Mount Sinai Hospital — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States
• Universitair Ziekenhuis Antwerpen — Edegem, Antwerp, Belgium
• CHU de Besancon — Besançon, France
• ICM Val d'Aurelle — Montpellier, France
• Hopital Saint-Louis — Paris, France
• CHU Rouen Normandie — Rouen, France
• Hôpital Saint Antoine Paris — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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