SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study
(SAFE-2 Trial)
Recruiting in Palo Alto (17 mi)
+15 other locations
PS
JL
Overseen byJeremie Lefevre, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: SafeHeal Inc
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Research Team
PS
Patricia Sylla, MD
Principal Investigator
MOUNT SINAI HOSPITAL
JL
Jeremie Lefevre, MD, PhD
Principal Investigator
Hopital Saint Antoine
Eligibility Criteria
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
See 1 more
Treatment Details
Interventions
- Colovac (Anastomosis Protection Device)
- Stoma Creation (Procedure)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ColovacExperimental Treatment1 Intervention
Patients receive Colovac during colorectal surgery
Group II: Standard of CareActive Control1 Intervention
Patients receive the standard of care, a protective stoma, during colorectal surgery
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Dartmouth-HitchcockLebanon, NH
Kaiser Permanente - Los AngelesLos Angeles, CA
USC Keck HospitalLos Angeles, CA
Cedars-Sinai Medical CenterLos Angeles, CA
More Trial Locations
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Who Is Running the Clinical Trial?
SafeHeal Inc
Lead Sponsor
Trials
4
Patients Recruited
270+