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TERMINATED
NCT03651076
NA

Traxi Panniculus Retractor for Cesarean Delivery

Sponsor: Beth Israel Deaconess Medical Center

View on ClinicalTrials.gov

Summary

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

Official title: Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery

Key Details

Gender

FEMALE

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2018-10-02

Completion Date

2025-02-01

Last Updated

2026-06-24

Healthy Volunteers

No

Interventions

DEVICE

Traxi panniculus retraction (Clinical Innovations, LLC)

class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy

Locations (2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States