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A Study to Evaluate the Safety and Effectiveness of the Standard of Care Diversion, Diverting Ileostomy, Following Low Anterior Resection

Clinical Trial Details

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard-of-care cancer treatment.
   
The data from this study could serve as the historical control arm data of a SafeHeal Colovac Colorectal Anastomosis Protection Device Evaluation (SAFE-3) Pivotal Study designed as a prospective, non-randomized, sequential, controlled, multicenter trial comparing the investigational device, the next generation Colovac Anastomosis Protection Device, to the standard of care (SOC), diverting ostomy.
   
By doing this study, we hope to learn better understand healing times as well as potential problems that may occur during the healing process.

After surgery, the study doctor will ask participants to attend study visits at 1, 3, 6, and 9 months following surgery, and then at 12 months.

Key Eligibility: 

Inclusion Criteria:

  1. Adult patients (18 years of age or older)
  2. Eligible to undergo open or minimally invasive sphincter-sparing low anterior resection with planned diverting loop ileostomy for malignancy, based on multidisciplinary team recommendations.

Exclusion criteria: 

  1. Known allergy to nickel or other components of the Colovac System (not applicable for control cohort)
  2. Pregnant or nursing female subject

Detailed eligibility will be reviewed when you contact the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Brooklyn

Contact(s)

Rohit Rasane
646-962-2789
rkr4004@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2405027546

ClinicalTrials.gov:

NCT06152276

Sponsor:

SH-SOC23

Status

Open to Enrollment

Age Group

Adult

Sponsor