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midazolam delivery via intravenous for Vasectomy

Phase 4
Waitlist Available
Research Sponsored by University of Tennessee Graduate School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* all men who request no-scalpel vasectomy procedure
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

Purpose: This study compared administration of midazolam via intravenous route with nasal atomizer route for moderate sedation in an office-based vasectomy clinic.

Eligible Conditions
  • Vasectomy
  • Sedation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Patient Questionnaire (generated by institution)
Secondary study objectives
Nursing Questionnaire (generated by institution)
Other study objectives
Surgeon Questionnaire (generated by institution)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: midazolam delivery via intravenousActive Control1 Intervention
normal sedation given via Intravenous route
Group II: midazolam delivery via nasal atomizerActive Control1 Intervention
normal sedation given via nasal atomizer

Find a Location

Who is running the clinical trial?

University of Tennessee Graduate School of MedicineLead Sponsor
13 Previous Clinical Trials
1,124 Total Patients Enrolled
Jennifer Ferris, PhdStudy DirectorUTGSM
~4 spots leftby Nov 2025
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