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Traxi Panniculus Retractor for Cesarean Delivery
Sponsor: Beth Israel Deaconess Medical Center
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
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