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Compares treatment options for Vasectomy
Official title A Trial of Self-Adjusted Nitrous Versus Placebo During Office Vasectomy
ClinicalTrials.gov ID: NCT07245628
What this study is testing
What is Nitrous Oxide?
Nitrous Oxide is an investigational medicine, being studied as a potential treatment for vasectomy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to see if nitrous oxide is safe and effective to use during during vasectomies performed in a clinic/in-office setting. This trial will compare self-administered nitrous oxide versus a placebo (oxygen) during office vasectomy.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85, men only
You may be able to join if
- Age 18 - 85 at the time of screening
- Desiring vasectomy for family planning purposes
- Able to understand and complete patient questionnaires
- Willing and able to provide written consent to participate in the study
You likely can't join if
- Patients with unilateral absence of the vas deferens
- Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
- Patients who decline office vasectomy and request monitored anesthesia care
- Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
- Patients with contraindications to nitrous oxide including:
- Inner ear, bariatric, or eye surgery within the past 2 weeks
See the full eligibility criteria
- Age 18 - 85 at the time of screening
- Desiring vasectomy for family planning purposes
- Able to understand and complete patient questionnaires
- Willing and able to provide written consent to participate in the study
- Patients with unilateral absence of the vas deferens
- Patients who are deemed by study surgeons to have anatomy no amendable for office procedure
- Patients who decline office vasectomy and request monitored anesthesia care
- Patients taking benzodiazepine or narcotic medication daily or within 24 hours of the procedure
- Patients with contraindications to nitrous oxide including:
- Inner ear, bariatric, or eye surgery within the past 2 weeks
- Current emphysematous blebs
- Severe B-12 deficiency
- History of bleomycin chemotherapy within the last year
- Class III or higher heart failure
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.