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Ultrasound Evaluation for Surgery Selection (PUP-VNOTES Trial)

N/A

Recruiting

Led By Aya Mohr-Sasson

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from operation until one month post-operation

Awards & highlights

PUP-VNOTES Trial Summary

This trial aims to study if pre-op ultrasound can help select women for vNOTES surgery, taking into account their history of PID or endometriosis.

Who is the study for?

This trial is for women who are scheduled to have a hysterectomy or surgery on the ovaries/fallopian tubes and are candidates for vNOTES, a less invasive surgical technique. They should have normal vaginal exams but no history of pelvic radiation, cancer, or current surgeries for prolapse or urinary issues.Check my eligibility

What is being tested?

The study tests if using trans-vaginal ultrasound before surgery can help doctors decide better who's fit for vNOTES—a minimally invasive procedure done through the vagina—especially in patients with past infections or endometriosis.See study design

What are the potential side effects?

Since this trial involves an ultrasound evaluation rather than medication, typical drug side effects aren't expected. However, there may be minor discomfort associated with undergoing an ultrasound.

PUP-VNOTES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from recruitment in the clinics until one month post operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from recruitment in the clinics until one month post operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from recruitment in the clinics until one month post operation for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The rate of adhesions/ complicated entry to the Douglas space reported during surgery.

Secondary outcome measures

Organ damage

PUP-VNOTES Trial Design

1Treatment groups

Experimental Treatment

Group I: Candidates for vaginal natural orifice trans-luminal surgery approachExperimental Treatment1 Intervention

Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery approach

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trans-vaginal ultrasound

2014

N/A

~1470

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

904 Previous Clinical Trials

320,885 Total Patients Enrolled

3 Trials studying Surgery

340 Patients Enrolled for Surgery

Aya Mohr-SassonPrincipal InvestigatorThe University of Texas Health Science Center, Houston, TX

2 Previous Clinical Trials

190 Total Patients Enrolled

2 Trials studying Surgery

190 Patients Enrolled for Surgery

Media Library

Candidates for vaginal natural orifice trans-luminal surgery approach Clinical Trial Eligibility Overview. Trial Name: NCT05623514 — N/A

Surgery Research Study Groups: Candidates for vaginal natural orifice trans-luminal surgery approach

Surgery Clinical Trial 2023: Candidates for vaginal natural orifice trans-luminal surgery approach Highlights & Side Effects. Trial Name: NCT05623514 — N/A

Candidates for vaginal natural orifice trans-luminal surgery approach 2023 Treatment Timeline for Medical Study. Trial Name: NCT05623514 — N/A

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 signed up for the experiment?

"Affirmative. According to clinicaltrials.gov, this research trial is currently open for enrolment and was initially published on May 16th 2022 before being recently updated on May 17th 2023. It aims to recruit 75 individuals from a single site."

Answered by AI

Are there any opportunities for volunteers to join this research endeavor?

"Affirmative. According to information found on clinicaltrials.gov, this medical trial is currently enrolling participants and was initially posted on May 16th 2022. As of today, the study requires 75 individuals at one site for completion - with the last edit being made on May 17th 2023."

Answered by AI