Safety Evaluation of the ADAM System

• ClinicalTrials.gov Identifier: NCT05134428
• Recruitment Status: Recruiting
• First Posted: November 26, 2021
• Last Update Posted: April 18, 2022
• Sponsor: Contraline, Inc
• Information provided by (Responsible Party): Contraline, Inc

Tracking Information

• First Submitted Date: November 13, 2021
• First Posted Date: November 26, 2021
• Last Update Posted Date: April 18, 2022
• Estimated Study Start Date: April 7, 2022
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 13, 2021)

Adverse Events [ Time Frame: 30 Days ]

The primary endpoint is the number of all treatment-emergent adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 13, 2021)

• Serious AEs [ Time Frame: 30 Days ]
  Number and percentage of subjects experiencing procedure and device-related serious adverse events at 30 days
• Adverse Events of Interest [ Time Frame: 3 years ]
  Number and percentage of subjects experiencing an adverse event of interest during the study
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety Evaluation of the ADAM System
• Official Title: Open-label, Single Arm, Multi-Centre, Prospective First-in-Human Study to Assess the Safety of the ADAM™ System
• 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.

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Device Feasibility

Condition

• Azoospermia
• Oligospermia

Intervention

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.

Study Arms

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.

Intervention: Device: ADAM System

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 13, 2021): 25
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Tammy Clark, MPH; (434) 218-6668; tammy@contraline.com

Contact: Kevin Eisenfrats; (434) 218-6668; kevin@contraline.com

• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT05134428
• Other Study ID Numbers: ADM-012
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Contraline, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Contraline, Inc
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Kevin Eisenfrats; Contraline, Inc
• Principal Investigator: Nathan Lawrentschuk, MB, BS, PhD, FRACS; Epworth Healthcare

• PRS Account: Contraline, Inc
• Verification Date: April 2022