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Anastomosis Protection Device

Colovac for Colorectal Cancer (SAFE-2 Trial)

N/A

Waitlist Available

Led By Patricia Sylla, MD

Research Sponsored by SafeHeal Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SAFE-2 Trial 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.

Eligible Conditions

Colorectal Cancer
Rectal Tumors
Rectal/Anal

SAFE-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Avoidance of ostomy

Safety Major Complications

SAFE-2 Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Colovac

2019

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

SafeHeal IncLead Sponsor

2 Previous Clinical Trials

223 Total Patients Enrolled

Patricia Sylla, MDPrincipal InvestigatorMOUNT SINAI HOSPITAL

2 Previous Clinical Trials

105 Total Patients Enrolled

Jeremie Lefevre, MD, PhDPrincipal InvestigatorHopital Saint Antoine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the size of the cohort for this research endeavor?

"For the study to be realized, 372 patients that fit its selection criteria must be found. The sponsor of this trial is SafeHeal Inc, and they have chosen Maimonides Medical Center in Brooklyn, New york and Dartmouth-Hitchcock in Lebanon as primary locations for conducting it."

Answered by AI

How many institutional sites are overseeing this research project?

"This clinical trial is utilizing the medical expertise of Maimonides Medical Center in Brooklyn, New york, Dartmouth-Hitchcock in Lebanon, New hampshire and Mount Sinai Hospital in California. In addition to these major sites, this study has also established 10 additional locations."

Answered by AI

Are there any available spots left for participants in this experiment?

"Affirmative. According to data provided by clinicaltrials.gov, the trial is presently recruiting participants. It was first announced on January 17th 2022 and has been amended as recently as December 5th 2022; it requires 372 patients across 10 locations for full enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2022. "SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-2) Pivotal Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05010850.