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Vessel Sealing Device

Vessel Sealing Device vs Conventional Suturing for Pelvic Organ Prolapse

N/A
Waitlist Available
Led By Jennifer Yeung, DO
Research Sponsored by Marlana McDowell
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Underwent vaginal hysterectomy with vaginal vault suspension
Underwent procedures for stress urinary incontinence
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-6 hours postoperative
Awards & highlights

Study Summary

This trial will compare pain outcomes for patients undergoing vaginal hysterectomy with pelvic reconstructive surgery using a new vessel sealing device as compared to conventional methods.

Who is the study for?
This trial is for English-speaking women who can consent and are undergoing vaginal hysterectomy with pelvic reconstructive surgery, including vault suspension and possible removal of fallopian tubes or ovaries. It's not for those using daily pain meds, pregnant, having other complex surgeries like anal repair or mesh use, or with chronic pelvic pain under treatment.Check my eligibility
What is being tested?
The study compares postoperative pain in patients using the LigaSureTM vessel sealing device versus traditional clamping and suturing during vaginal hysterectomy and pelvic reconstruction. The goal is to see if the new device reduces pain after surgery.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, common ones from surgical procedures may include discomfort at the incision site, swelling, bruising, risk of infection, bleeding complications, and general anesthesia risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a vaginal hysterectomy with support for the top of my vagina.
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I have had surgery for stress urinary incontinence.
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I have had my fallopian tubes or ovaries removed.
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I have had surgery to repair the front and/or back walls of my vagina.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-6 hours postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-6 hours postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Pain
Secondary outcome measures
Abdominal Pain
Vaginal Pain

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Vessel sealing deviceExperimental Treatment1 Intervention
Vessel sealing device to be utilized for vaginal hysterectomy
Group II: Conventional clamping and suturing methodActive Control1 Intervention
Vaginal hysterectomy will be performed utilizing conventional Heaney clamps, scissors, and suturing material.

Find a Location

Who is running the clinical trial?

Marlana McDowellLead Sponsor
TriHealth Hatton Research InstituteOTHER
4 Previous Clinical Trials
352 Total Patients Enrolled
Jennifer Yeung, DOPrincipal InvestigatorTriHealth Inc.
1 Previous Clinical Trials
310 Total Patients Enrolled

Media Library

LigaSureTM vessel sealing device (Vessel Sealing Device) Clinical Trial Eligibility Overview. Trial Name: NCT05192954 — N/A
Pelvic Organ Prolapse Research Study Groups: Vessel sealing device, Conventional clamping and suturing method
Pelvic Organ Prolapse Clinical Trial 2023: LigaSureTM vessel sealing device Highlights & Side Effects. Trial Name: NCT05192954 — N/A
LigaSureTM vessel sealing device (Vessel Sealing Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05192954 — N/A

Frequently Asked Questions

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

Are applications for participation still being accepted in this research endeavor?

"Correct. As evidenced on clinicaltrials.gov, this medical experiment— originally posted in January of 2022 — is presently searching for enrollees. To complete the study, 100 human test subjects need to be recruited from two distinct locations."

Answered by AI

How much participation has been seen in this research endeavor?

"Affirmative. As per the information provided on clinical trials,gov, this medical endeavour is currently enrolling participants. This study was first published on January 28th 2022 and has been updated as recently as May 3rd of the same year. The trial seeks to enlist 100 patients from two distinct locations."

Answered by AI

Does this medical trial accept individuals aged 40 and above?

"This medical trial is recruiting patients aged 18 to 80. Those younger than this and senior citizens can look into the 72 trials tailored for minors and 441 studies suitable for elderly individuals respectively."

Answered by AI

Are there any participant criteria that would exclude me from joining this clinical trial?

"Those eligible for enrollment must be between 18 and 80 years old, and have a diagnosis of pelvic organ prolapse. This clinical trial is looking to enroll 100 participants in total."

Answered by AI
~32 spots leftby Mar 2025