5 Participants Needed

Delivery Lumen Access Device for Vasectomy

Recruiting at 1 trial location
Age: 18+
Sex: Male
Trial Phase: Academic
Sponsor: Next Life Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will evaluate the safety and usability of the Delivery Lumen Access Device (DLAD) in accessing the vas deferens in up to 30 healthy males. This is a prospective, non-randomized, open label interventional study.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is the Delivery Lumen Access Device for vasectomy safe for humans?

The safety of vasectomy techniques, including those using devices like the Delivery Lumen Access Device, generally shows low complication rates. Common issues can include minor bleeding, infection, and pain, but long-term negative effects are not proven. The experience of the surgeon and the technique used are important for minimizing risks.12345

How does the Delivery Lumen Access Device treatment for vasectomy differ from other treatments?

The Delivery Lumen Access Device for vasectomy is unique because it potentially offers a reversible method of blocking the vas deferens (the tube that carries sperm), unlike traditional vasectomy methods that are typically permanent. This device uses silicone plugs that can be removed to restore sperm flow, providing a novel option for men who may want to reverse the procedure in the future.26789

Who Is on the Research Team?

DW

Darlene Walley

Principal Investigator

Next Life Sciences

Are You a Good Fit for This Trial?

This trial is for healthy men aged 18 to 65 who have decided to get a vasectomy. Participants must be in good health as confirmed by medical history and physical examination, agree to the study's procedures by signing a consent form, and be considered suitable for a vasectomy as long-term contraception.

Inclusion Criteria

I am a man planning to have a vasectomy.
I am a man who has signed the consent form for this study.
I am healthy enough for a vasectomy, as confirmed by my doctor.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants undergo the DLAD procedure during their vasectomy to test the device's safety and usability

Perioperative
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, including a 14-day post-procedure check for adverse events

2 weeks
1 visit (telephone or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Delivery Lumen Access Device
Trial Overview The Delivery Lumen Access Device (DLAD) is being tested on up to 30 males undergoing vasectomies. The study aims to assess the safety and usability of DLAD when accessing the vas deferens. It's an open-label, non-randomized interventional study without comparison groups.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Next Life Sciences

Lead Sponsor

Trials
1
Recruited
30+

Southern Star Research

Industry Sponsor

Trials
14
Recruited
630+

Citations

Vasectomy: an update. [2008]
Vasectomy with vessel sealing device: comparison of different diameters. [2019]
[Long-term effect and safety of non-occlusive intra-vas device for male contraception]. [2013]
[Ambulatory vasectomy. Risks and complications]. [2018]
Efficacy of percutaneous vas occlusion compared with conventional vasectomy. [2019]
Development of a potentially reversible vas deferens occlusion device and evaluation in primates. [2019]
Development of reversible vas deferens occlusive device: IV. Rigid prosthetic devices. [2017]
Use of surgical clips prevents suture slippage when ligating folded vas deferens during vasectomy. [2010]
Vasectomy reversal: decision making and technical innovations. [2022]
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