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Live Surgery with VITOM for Vaginal Vault Prolapse (VITOM Trial)

N/A
Waitlist Available
Led By Sean Francis, M.D.
Research Sponsored by University of Louisville
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 22 months
Awards & highlights

Summary

This is research in which students are queried by questionnaires on their satisfaction with and experience with certain educational practices (use of a camera image projecting during a live surgery) or with pre-recorded video. As data collection only involves survey data collection and satisfaction with an educational experience, and randomization/intervention is only involving use of one type of educational method versus another .

Eligible Conditions
  • Vaginal Vault Prolapse
  • Fistula
  • Vaginal Prolapse
  • Urinary Incontinence
  • Pelvic Organ Prolapse

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Learner satisfaction

Trial Design

4Treatment groups
Active Control
Group I: Live Surgery with VITOMActive Control1 Intervention
Learner will not assist during the surgery, but watch the live surgery that is projected on a screen via the VITOM camera followed by a short questionnaire.
Group II: Live Surgery without VITOMActive Control1 Intervention
Learner will assist in the traditional manner without the use of the VITOM camera followed by a short questionnaire.
Group III: Video viewing with VITOMActive Control1 Intervention
Learner will watch a video taped using the VITOM camera followed by a short questionnaire.
Group IV: Video viewing with standard cameraActive Control1 Intervention
Learner will watch a video taped using the standard hand-held high definition camera followed by a short questionnaire.

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Who is running the clinical trial?

KARL STORZ Endoscopy-America, Inc.Industry Sponsor
11 Previous Clinical Trials
21,298 Total Patients Enrolled
University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,188 Total Patients Enrolled
Sean Francis, M.D.Principal InvestigatorUniversity of Louisville School of Medicine
1 Previous Clinical Trials
90 Total Patients Enrolled
~16 spots leftby Sep 2025
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