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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
Must not have
Disruption of abdominal skin (infection, rash, abrasion, laceration)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 6 to 8 weeks
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have no skin issues (like cuts or rashes) on my belly.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
855 Previous Clinical Trials
12,930,721 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
1,666 Previous Clinical Trials
11,841,384 Total Patients Enrolled
48 Trials studying Obesity
278,124 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
~3 spots leftby Jan 2025
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