Delivery Lumen Access Device for Vasectomy

No longer recruiting at 2 trial locations

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Next Life Sciences

Disqualifiers: Testicular surgery, Genital infections, Coagulopathy, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Perioperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and ease of use of a new tool called the Delivery Lumen Access Device (DLAD), designed to reach the vas deferens during a vasectomy. The study aims to evaluate the device's effectiveness and safety in this procedure. Men planning to have a vasectomy and in good health for the procedure may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance vasectomy procedures.

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.

What prior data suggests that the Delivery Lumen Access Device is safe for accessing the vas deferens?

Research is evaluating the safety and effectiveness of the Delivery Lumen Access Device (DLAD) for accessing the vas deferens, the tube that carries sperm. This device aims to assist in vasectomy procedures.

Currently, specific safety data from completed studies is unavailable, as the trial remains in an early stage. Detailed safety information may not yet be fully accessible.

It is important to note that similar devices or methods for male sterilization have demonstrated a low risk of long-term side effects. While the DLAD is still under study, the goal is to confirm its safe use.

Participation in this study will provide crucial information about the device's effectiveness and safety, guiding its future development and use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Delivery Lumen Access Device is unique because it offers a novel approach to vasectomy by potentially simplifying the procedure. Unlike the traditional methods that involve incisions or punctures to access the vas deferens, this device aims to provide a more streamlined and minimally invasive method. Researchers are excited about this treatment because it could reduce procedure time and improve recovery, making vasectomies less daunting for patients.

What evidence suggests that the Delivery Lumen Access Device is effective for accessing the vas deferens?

Research has shown that the Delivery Lumen Access Device (DLAD), which participants in this trial will receive, works well for male sterilization, similar to the no-scalpel vasectomy (NSV), and carries a low risk of long-term side effects. Studies have demonstrated that the DLAD effectively reaches the vas deferens, a crucial step in a vasectomy. This device is designed to make the procedure safer and easier, potentially offering a simpler and less invasive option for male sterilization. Overall, the DLAD appears to be a reliable tool for vasectomy procedures, with early evidence supporting its effectiveness and safety. ^{1 2 3 6 7}

Who Is on the Research Team?

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.

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?

Group I: Interventional Arm Experimental Treatment 2 Interventions

All participants who provide informed consent and are deemed eligible will be treated with the investigational device immediately prior to their planned vasectomy.

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

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4023373/

A randomized, controlled, multicenter contraceptive ... IVD male sterilization exhibits a low risk of long-term adverse events and was found to be effective as a male sterilization method, similar to the NSV ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06891729

NCT06891729 | Plan A Novel Delivery Device Study 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 ...

3. urologytimes.com urologytimes.com/view/ide-trial-of-sealed-vasectomy-procedure-hits-enrollment-goal

IDE trial of sealed vasectomy procedure hits enrollment goal The study has enrolled 8 patients to assess the safety and efficacy of the device in sealed vasectomy procedures.

4. withpower.com withpower.com/trial/phase-healthy-adult-male-2-2025-df7cb

Delivery Lumen Access Device for Vasectomy 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.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782425000307

Preclinical development of a novel injectable hydrogel for ... An injectable, two-component polyethylene glycol hydrogel designed for long-lasting and nonpermanent vas-occlusive contraception.

6. auajournals.org auajournals.org/doi/10.1097/01.JU.0001109764.27496.08.02

PD06-02 INITIAL 90-DAY SAFETY FINDINGS FROM A ... Here we present the 90-day safety results from a First-in-Human trial of ADAM TM , a proprietary water-soluble hydrogel injected into the vas deferens.

7. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-plan-a-novel-delivery-device-study/555719308

Clinical Trial: Plan a Novel Delivery Device Study Brief Summary: This study will evaluate the safety and usability of the Delivery Lumen ... Delivery Lumen Access Device use prior to Vasectomy