← Back to Search

NA

Traxi Panniculus Retractor for Cesarean Delivery

N/A
Recruiting
Led By Ai-ris Collier, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing non-emergent cesarean delivery
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 6 to 8 weeks
Awards & highlights

Study Summary

This trial will compare outcomes of cesarean delivery for obese women with and without the use of the Traxi device.

Who is the study for?
This trial is for morbidly obese pregnant women with a BMI of 40 or higher who are planning a non-emergent cesarean delivery. They must be able to give informed consent and have a single baby. Women can't join if they have skin issues on their belly, an allergy to adhesives, or if the baby has passed away.Check my eligibility
What is being tested?
The study is testing the Traxi panniculus retractor during cesarean deliveries in morbidly obese women to see if it improves surgical outcomes, breathing function during surgery, and satisfaction levels for both patients and healthcare providers.See study design
What are the potential side effects?
Since the Traxi panniculus retractor is a physical device used during surgery rather than a drug, side effects may include discomfort at the site of application or potential skin irritation from adhesive materials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a planned cesarean delivery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 6 to 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 6 to 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cesarean delivery operative time
Secondary outcome measures
Change in pulmonary function (forced expiratory volume)
Change in pulmonary function (forced vital capacity)
Patient satisfaction assessed by a questionnaire
+1 more
Other outcome measures
Composite neonatal outcome
Estimated blood loss
Hospital length of stay
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Traxi panniculus retraction groupExperimental Treatment1 Intervention
The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
Group II: Standard of careActive Control1 Intervention
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,009,994 Total Patients Enrolled
22 Trials studying Obesity
780 Patients Enrolled for Obesity
Clinical Innovations, LLCIndustry Sponsor
5 Previous Clinical Trials
862 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,611 Previous Clinical Trials
11,470,279 Total Patients Enrolled
46 Trials studying Obesity
78,175 Patients Enrolled for Obesity

Media Library

Traxi Panniculus Retractor (NA) Clinical Trial Eligibility Overview. Trial Name: NCT03651076 — N/A
Obesity Clinical Trial 2023: Traxi Panniculus Retractor Highlights & Side Effects. Trial Name: NCT03651076 — N/A
Traxi Panniculus Retractor (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03651076 — N/A
Obesity Research Study Groups: Traxi panniculus retraction group, Standard of care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Traxi Panniculus Retractor for Cesarean Delivery
Ai-ris Collier 2018. "Traxi Panniculus Retractor for Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03651076.
All > Morbid Obesity
~26 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top