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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05134428




Registration number
NCT05134428
Ethics application status
Date submitted
13/11/2021
Date registered
26/11/2021

Titles & IDs
Public title
A First in Human Study, Evaluating the Safety and Efficacy of ADAM™ 1.0
Scientific title
Open-label, Dose Ranging, Multi-Centre, Prospective First in Human Study to Assess the Safety of the ADAM System
Secondary ID [1] 0 0
ADM-012
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Male Contraception 0 0
Healthy Male Adults 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ADAM System

Experimental: ADAM Cohort 1 - The first 5 subjects will be reviewed for safety by a Data Safety Monitoring Board (DSMB) at 30 days post-implantation. The 5 subjects will then be followed up to 24 months or until their semen analyses is = 15 million sperm/mL.

Experimental: ADAM Cohort 2 - An additional 13 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is = 15 million sperm/mL.

Experimental: ADAM Cohort 3 - An additional 4 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is = 15 million sperm/mL.

Experimental: ADAM Cohort 4 - An additional 3 subjects will be enrolled and implanted with ADAM. They will be followed up to 24 months or until or until their semen analyses is = 15 million sperm/mL.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events
Timepoint [1] 0 0
30 Days
Secondary outcome [1] 0 0
Serious AEs
Timepoint [1] 0 0
30 Days
Secondary outcome [2] 0 0
Adverse Events of Interest
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Azoospermia
Timepoint [3] 0 0
3 years

Eligibility
Key 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)
Minimum age
25 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Other
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
Other
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/02/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
South Coast Urology - Wollongong
Recruitment hospital [2] 0 0
AndroUrology - Brisbane
Recruitment hospital [3] 0 0
Epworth HealthCare - E. Melbourne
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment postcode(s) [2] 0 0
4001 - Brisbane
Recruitment postcode(s) [3] 0 0
3002 - E. Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Contraline, Inc
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Alex Pastuszak, MD, PhD
Address 0 0
Contraline, Inc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05134428