Obesity, MorbidNCT03651076
Traxi Panniculus Retractor for Cesarean Delivery
A study testing Traxi panniculus retraction (Clinical Innovations, LLC) in people with Obesity, Morbid and Cesarean Section Complications, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Obesity, Morbid, Cesarean Section Complications
- What is being tested?
- Traxi panniculus retraction (Clinical Innovations, LLC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Oct 2018to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant
- BMI greater than or equal to 40 kg/m^2
- Undergoing non-emergent cesarean delivery
- Able and willing to provide written, informed consent
- Singleton gestation
Who cannot join
- Fetal demise
- Disruption of abdominal skin (infection, rash, abrasion, laceration)
- Known adhesive allergy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
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.
Read the detailed description
Morbidly obese women (BMI >/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to Traxi panniculus retraction or standard of care for panniculus retraction.
The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel.
A secondary aim of the study is to evaluate the hypothesis that the Traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. To do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer.
A tertiary aim of the study is to evaluate the hypothesis that the Traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. Patient and provider-reported outcomes will be evaluated using surveys.
- Conditions
- Obesity, Morbid, Cesarean Section Complications
- Being tested
- Traxi panniculus retraction (Clinical Innovations, LLC)
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traxi panniculus retraction (Clinical Innovations, LLC)Device
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
| Study group | Role | What they receive |
|---|---|---|
| Traxi panniculus retraction group | Experimental | The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider. Receives: Device: Traxi panniculus retraction (Clinical Innovations, LLC) |
| Standard of care | No intervention | Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean Delivery Operative Time
time from skin incision to closure during cesarean delivery
Measured: during cesarean delivery
Secondary outcomes (4)
Change in Pulmonary Function (Forced Vital Capacity)
measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method, immediately prior to cesarean delivery
Measured: Immediately prior to cesarean delivery
Change in Pulmonary Function (Forced Expiratory Volume)
measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method, immediately prior to cesarean delivery
Measured: Immediately prior to cesarean delivery
Patient Satisfaction Assessed by a Questionnaire
patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
Measured: through study completion, approximately 6 to 8 weeks
Provider Satisfaction With a Survey
provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
Measured: through study completion, approximately 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start2 Oct 2018
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Why it stopped: Slow accrual due to provider preference
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Innovations, LLC, Brigham and Women's Hospital
- Responsible party
- Principal investigator, Ai-ris Collier, Beth Israel Deaconess Medical Center
- Investigators
- Ai-ris Y Collier, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03651076
- Sponsor's protocol ID
- 2018P000369
- Status last verified
- May 2026
- First submitted
- 18 Jul 2018
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03651076
- Acronym / sponsor ID
- 2018P000369
- Conditions
- Obesity, Morbid, Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual due to provider preference
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Clinical Innovations, LLC, Brigham and Women's Hospital
- Study start
- 2 Oct 2018 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Posted 24 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Morbidly obese women (BMI >/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to Traxi panniculus retraction or standard of care for panniculus retraction.
The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel.
A secondary aim of the study is to evaluate the hypothesis that the Traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. To do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer.
A tertiary aim of the study is to evaluate the hypothesis that the Traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. Patient and provider-reported outcomes will be evaluated using surveys.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traxi panniculus retraction group | Experimental | Device: Traxi panniculus retraction (Clinical Innovations, LLC)The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider. |
| Standard of care | No intervention | –Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant
- BMI greater than or equal to 40 kg/m^2
- Undergoing non-emergent cesarean delivery
- Able and willing to provide written, informed consent
- Singleton gestation
Key exclusion criteria (3 listed)
- Fetal demise
- Disruption of abdominal skin (infection, rash, abrasion, laceration)
- Known adhesive allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traxi panniculus retraction (Clinical Innovations, LLC)class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy | Device | Traxi panniculus retraction group |
Primary outcome
Cesarean Delivery Operative Time
Time frame: during cesarean delivery
time from skin incision to closure during cesarean delivery
4 secondary outcomes
Change in Pulmonary Function (Forced Vital Capacity)
Time frame: Immediately prior to cesarean delivery
Change in Pulmonary Function (Forced Expiratory Volume)
Time frame: Immediately prior to cesarean delivery
Patient Satisfaction Assessed by a Questionnaire
Time frame: through study completion, approximately 6 to 8 weeks
Provider Satisfaction With a Survey
Time frame: through study completion, approximately 6 to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
Related trials for Obesity, Morbid
Active, not recruiting
Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial
Bariatric Surgery Candidate, Obesity
Active, not recruiting
Mindfulness Based Eating Awareness Training for Bariatric Surgery Patients
Obesity, Morbid, Eating Disorder Symptom
RecruitingPhase 3
Fiber and Metformin Combination Therapy in Adolescents With Severe Obesity and Insulin Resistance
Obesity, Childhood, Insulin Resistance
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ai-ris Y Collier, MD principal investigator
Beth Israel Deaconess Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traxi panniculus retraction (Clinical Innovations, LLC) in people with Obesity, Morbid and Cesarean Section Complications, run by Beth Israel Deaconess Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean Delivery Operative Time (time frame: during cesarean delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.