Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001459516
Ethics application status
Approved
Date submitted
12/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
This is the first study in humans to test the safety, effectiveness, and practicality of ADAM™ 2.0, a biocompatible contraceptive implant. This implant is designed to be tested in men with normal fertility levels who are considering a vasectomy as a contraceptive option.
Scientific title
Open-label, Multi-Centre, First-in-Human Study to Assess the Safety, Efficacy and Feasibility of Implanting ADAM™ 2.0 in Fertile Males Who Are Suitable for a Vasectomy.
Secondary ID [1] 313244 0
ADM-014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Contraception 335561 0
Condition category
Condition code
Reproductive Health and Childbirth 332132 332132 0 0
Contraception

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ADAM™ 2.0 is a male contraceptive device designed to block sperm flow through the vas deferens as an alternative non-hormonal, non-permanent option to a traditional vasectomy. The intervention involves the implantation of a pre-formed hydrogel implant into the vas deferens. Delivered via a minimally invasive 15-30 minute procedure, similar to a non-scalpel vasectomy, performed by a urological surgeon with 10+ years of experience. All participating surgeons will receive 2 hours of hands-on device training 1 week prior to their first procedures, surgeons will be trained by Contraline’s chief medical officer and chief technology officer. The procedure can be carried out under local or general anaesthesia, depending on surgeon decision, and will be performed in a hospital environment with the entire procedure visit taking approximately 5 hours. Participants will have in-person visits with the investigator (30 minutes each) at screening, 14 days, 30 days, 90 days, 6 months, 12 months, 18 months, and 24 months, as well as telephone visits with the study coordinator (10 minutes) at 7 days, 60 days, 4 months, 5 months, 7 months, 8 months, 9 months, 10 months, 11 month, 15 months and 21 months to monitor safety, effectiveness, and any potential complications. The intervention is standardized across participants. All visits will be used to assess the device's placement, monitor for side effects, and gather data on its long-term efficacy, with adherence to the protocol closely monitored through regular follow-ups and participant questionnaires.
Intervention code [1] 329824 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339709 0
Safety of ADAM™ 2.0
Timepoint [1] 339709 0
7 days, 14 days, 30 days, 60 days, 90 days, 6 months, 9 months, 12 months, 18 months and 24 months post implantation procedure.
Secondary outcome [1] 440965 0
Efficacy of ADAM 2.0
Timepoint [1] 440965 0
Day 7, Day 14, Day 30, Day 60. Day 90, 6 month, 9 month, 12 month, 18 month and 24 months after implantation.
Secondary outcome [2] 440967 0
Feasibility of implanting ADAM 2.0
Timepoint [2] 440967 0
During implantation procedure.

Eligibility
Key inclusion criteria
Potential participants must meet ALL the following criteria to be eligible for enrolment into the study:
1. Participant is male.
2. Participant is 25 to 55 years of age (at the time of consent).
3. Participants semen analysis is greater than or equal to 16 million sperm/mL and greater than or equal to 42% total motility (in line with the World Health Organization (WHO) Laboratory Manual for the Examination and Processing of Human Semen). Results are to be evaluated from 2 semen samples obtained between no less than 2 days and no more than 7 days apart.
4. Participant is seeking and suitable to undergo a vasectomy as a long-term form of contraception.
5. Able to provide voluntary, written informed consent with comprehension of all aspects of the protocol, prior to any study procedures.
6. In the opinion of the investigator, the participant 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. Participant agrees to use an alternative method of contraception with any female partner of childbearing potential during the course of the study until study exit occurs.
8. Participant is willing to accept an unknown risk of conceiving a pregnancy during the duration of the study.
9. The participant has been informed of the nature of the study, agrees to its provisions, and has willingly provided written informed consent.
Minimum age
25 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Potential participants will be excluded if ANY of the following criteria apply:
1. Participants who have previously participated in a trial involving ADAM™ or are currently enrolled in another interventional clinical trial or have participated in a trial within the 3 months prior to screening, will be excluded.
2. Participant has history of prior hormonal therapy use (eg, androgenic steroids, gonadotropin-releasing hormone agonists and antagonists) within the past 6 months from the screening visit.
3. Participant on exam has any of the following: vas not present, abnormal scrotum, large varicocele, hydrocele, filariasis or elephantiasis of scrotum, or intra-scrotal mass that would make the participant not suitable for the study.
4. Participant has a known allergic reaction to polyethylene glycol containing products or has had a prior severe allergic response to injectable or implantable devices.
5. Participant has local genital infections such as balanitis, scrotal skin infection, epididymitis, or orchitis, or tender (inflamed) tip of the penis, but may be enrolled after resolution of an acute infection.
6. Participant has current coagulopathy or other bleeding disorders.
7. Participant currently taking or planning to take any type of systemic medication which could affect sperm count or ejaculation (eg, anabolic steroids, chemotherapy, alpha blocker).
8. Participant had a previous successful or unsuccessful vasectomy or vasectomy reversal.
9. Participant has any clinically significant abnormal findings or other findings identified by the investigator that would exclude the participant.
10. Participant is without access to telephone and/or ability to gain technology access.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
31/10/2027
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 27263 0
Epworth Freemasons (Clarendon Street) - East Melbourne
Recruitment hospital [2] 27264 0
Wollongong Private Hospital - Wollongong
Recruitment hospital [3] 27265 0
St Andrew's War Memorial Hospital - Brisbane
Recruitment postcode(s) [1] 43350 0
3002 - East Melbourne
Recruitment postcode(s) [2] 43351 0
2500 - Wollongong
Recruitment postcode(s) [3] 43352 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 317687 0
Commercial sector/Industry
Name [1] 317687 0
Contraline Australia Pty Ltd.
Country [1] 317687 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Contraline Australia Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 320015 0
None
Name [1] 320015 0
Address [1] 320015 0
Country [1] 320015 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316385 0
UnitingCare Health Human Research Ethics Committee
Ethics committee address [1] 316385 0
Ethics committee country [1] 316385 0
Australia
Date submitted for ethics approval [1] 316385 0
29/10/2024
Approval date [1] 316385 0
Ethics approval number [1] 316385 0
Ethics committee name [2] 316390 0
Bellberry Human Research Ethics Committee G
Ethics committee address [2] 316390 0
Ethics committee country [2] 316390 0
Australia
Date submitted for ethics approval [2] 316390 0
06/11/2024
Approval date [2] 316390 0
10/12/2024
Ethics approval number [2] 316390 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137730 0
Prof Nathan Lawrentschuk
Address 137730 0
Epworth HealthCare, 124 Grey St, East Melbourne VIC 3002
Country 137730 0
Australia
Phone 137730 0
+61 03 9483 6035
Fax 137730 0
Email 137730 0
Nathan.Lawrentschuk2@mh.org.au
Contact person for public queries
Name 137731 0
Daniel Shokouhi
Address 137731 0
E.J. Whitten Prostate Cancer Research Centre, 109 Albert Street, East Melbourne VIC 3002
Country 137731 0
Australia
Phone 137731 0
+61 03 9483 6035
Fax 137731 0
Email 137731 0
ctc-urorenal@epworth.org.au
Contact person for scientific queries
Name 137732 0
Alex Pastuszak
Address 137732 0
Contraline Pty Ltd, 818 E Jefferson Street, Suite 201, Charlottesville, Virginia, 22902, USA
Country 137732 0
United States of America
Phone 137732 0
+1 415 412 2934
Fax 137732 0
Email 137732 0
alex@contraline.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.