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Safety Evaluation of the ADAM System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05134428
Recruitment Status : Recruiting
First Posted : November 26, 2021
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
Contraline, Inc

Study Description
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Brief Summary:
This study will evaluate the safety and feasibility of the ADAM System for implantation into the vas deferens in 25 healthy males at 2 sites. This is a prospective, non-randomized, open label interventional trial.

Condition or disease Intervention/treatment Phase
Azoospermia Oligospermia Device: ADAM System Not Applicable

Detailed Description:

There are two cohorts to monitor safety in this study:

  • Cohort 1: The first 10 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 10 subjects will then be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days).
  • Cohort 2: An additional 15 subjects will be enrolled and implanted with ADAM after the DSMB Safety Review of the first 10 subjects at 30 days. They will be followed up to 36 months or until the average of two semen analyses is ≥ 15 million sperm/mL (the duration between collection of both specimens is ≥2 days and ≤7 days).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Open-label, Single Arm, Multi-Centre, Prospective First-in-Human Study to Assess the Safety of the ADAM™ System
Estimated Study Start Date : April 7, 2022
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: ADAM System
All subjects who consent and meet inclusion and none of the exclusion will be enrolled and receive the ADAM System, which is a hydrogel device implanted into the vas deferens.
 Device: ADAM System
The ADAM System consists of an injectable hydrogel and delivery apparatus that is intended to provide long-lasting, non-permanent vasal occlusion for men, resulting in azoospermia. ADAM is designed to be inserted into the vasa deferentia through a minimally invasive procedure, similar to the no-scalpel vasectomy.


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 30 Days ]
    The primary endpoint is the number of all treatment-emergent adverse events


Secondary Outcome Measures :
  1. Serious AEs [ Time Frame: 30 Days ]
    Number and percentage of subjects experiencing procedure and device-related serious adverse events at 30 days

  2. Adverse Events of Interest [ Time Frame: 3 years ]
    Number and percentage of subjects experiencing an adverse event of interest during the study

  3. Azoospermia [ Time Frame: 3 years ]
    Percentage of subjects achieving absolute azoospermia, defined as a zero sperm count, and percentage of subjects achieving virtual azoospermia, defined as a sperm count of ≤100,000 per mL and 0% motility


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject is male
  2. Subject is 25 to 65 years of age
  3. Subject has a normal semen analysis (≥ 15 million sperm/mL, ≥40% total motility) defined by the WHO Laboratory Manual for the Examination and Processing of Human Semen (5th Edition), based on the average of two semen samples ≥2 days and ≤7 days apart
  4. Subject is suitable to undergo a vasectomy as a long-term form of contraception
  5. Subject is legally competent
  6. In the opinion of the Investigator, the subject is willing and able to comply with the protocol, return for all follow-up visits and complete all protocol assessments, which includes providing recurring semen samples
  7. Subject agrees to use an alternative method of contraception with any female partner of reproductive age during the course of the study treatment until study exit occurs
  8. Subject is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
  9. The subject has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent, approved by the appropriate Human Research Ethics Committee (HREC) -

Exclusion Criteria:

  • Potential subjects will be excluded if ANY of the following criteria apply:

    1. Subject is participating in another interventional clinical trial currently or within the past 3 months from the time of screening
    2. Subject has history of prior hormonal therapy use (e.g., androgenic steroids, GnRH agonists and antagonists) within the past 6 months
    3. Subject on exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intrascrotal mass that would make the subject not suitable for the study
    4. Subject has allergic reaction to polyethylene glycol (PEG) containing products or has had a prior severe allergic response to injectable or implantable devices
    5. Subject has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be admitted after resolution of an acute infection
    6. Subject has current coagulopathy or other bleeding disorders
    7. Subject currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (e.g., anabolic steroids, chemotherapy, alpha blocker)
    8. Subject had a previous successful or unsuccessful vasectomy or vasectomy reversal
    9. Subject has any clinically significant abnormal findings or other findings identified by Investigator that would exclude the subject.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05134428


Contacts
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Contact: Tammy Clark, MPH (434) 218-6668 tammy@contraline.com
Contact: Kevin Eisenfrats (434) 218-6668 kevin@contraline.com

Locations
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Australia, Victoria
Epworth HealthCare Recruiting
E. Melbourne, Victoria, Australia, 3002
Contact: David Zhang       ctc-urorenal@epworth.org.au   
Sponsors and Collaborators
Contraline, Inc
Investigators
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Study Director: Kevin Eisenfrats Contraline, Inc
Principal Investigator: Nathan Lawrentschuk, MB, BS, PhD, FRACS Epworth Healthcare
More Information
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Responsible Party: Contraline, Inc
ClinicalTrials.gov Identifier: NCT05134428    
Other Study ID Numbers: ADM-012
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Azoospermia
Oligospermia
Infertility, Male
Genital Diseases, Male
 Genital Diseases
Urogenital Diseases
Infertility
Male Urogenital Diseases