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Pannus Retractor

Retractor for Obesity (PANOUS Trial)

N/A

Waitlist Available

Led By Daniel Pasko, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 day per participant

Awards & highlights

PANOUS Trial Summary

This trial evaluates if using a pannus retractor adhesive can improve fetal anatomy ultrasound exams for people with a high BMI.

Eligible Conditions

Obesity
Fetal Abnormalities

PANOUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 day per participant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 day per participant

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 day per participant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adequate visualization of sixteen prespecified fetal anatomy ultrasound components

Secondary outcome measures

Adequate visualization of all fetal anatomy ultrasound components

Adverse effects

Detection of fetal anomalies

+4 more

PANOUS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RetractorExperimental Treatment1 Intervention

Research team members will apply a pannus retractor adhesive according to manufacturer's directions. The sonographer will be asked to attempt all views of the detailed anatomic survey before the adhesive is removed. If the sonographer thinks that additional views could be obtained with the adhesive removed using transabdominal or transvaginal imaging, this is acceptable based on the pragmatic design of this study.

Group II: No retractorActive Control1 Intervention

The detailed anatomic survey will proceed per normal protocol. Approaches may include transabdominal and transvaginal imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

traxi® Panniculus Retractor

2023

N/A

~170

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Who is running the clinical trial?

Prisma Health-UpstateLead Sponsor

82 Previous Clinical Trials

42,788 Total Patients Enrolled

4 Trials studying Obesity

19,616 Patients Enrolled for Obesity

Clemson UniversityOTHER

33 Previous Clinical Trials

5,743 Total Patients Enrolled

Daniel Pasko, MDPrincipal InvestigatorPrisma Health

1 Previous Clinical Trials

20 Total Patients Enrolled

1 Trials studying Obesity

20 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been recruited to participate in this experiment?

"Affirmative, the information available on clinicaltrials.gov suggests that this trial is actively seeking volunteers. This medical study was first published on March 10th 2023 and underwent a most recent edit four days later. 150 participants need to be recruited from one site."

Answered by AI

Is recruitment for this research still open to participants?

"Clinicaltrials.gov conveys that this trial is presently recruiting individuals, with the initial posting on March 10th 2021 and most recent update on March 13th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pannus Assistance Needed for Obstetric Ultrasound Studies

2023. "Pannus Assistance Needed for Obstetric Ultrasound Studies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05764408.