Male SterilizationPhase 1NCT00335361
Implantable Device for Male Reproductive Sterilization
A Phase 1 study testing Intra Vas Device (IVD) in people with Male Sterilization, run by Shepherd Medical Company at 3 sites in United States.
Trial summary
The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm. Ninety subjects from two centers in the United Stated will be followed closely for 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Sterilization
- What is being tested?
- Intra Vas Device (IVD)
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2006to Sep 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject desires to undergo a vasectomy.
- Freely consents to participate in the Study a
- Agrees to provide a semen sample at regularized periods for at least 30 months.
- Willing to use a redundant method of contraception until successful occlusion is confirmed.
- Agrees to provide follow-up information.
- Willing and able to understand and agree to follow all aspects of the procedures and Study requirements.
- At least 18 years of age.
Who cannot join
- Has a condition permanently or temporarily making participation in the Study inadvisable.
- Has a condition permanently or temporarily making a vasectomy inadvisable.
- Has had a previous successful/unsuccessful vasectomy.
- Has had an allergic reaction to silicone and/or ethylene.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Adult and Pediatric Urology
Sartell, Minnesota, 56377
Regional Urology, LLC
Shreveport, Louisiana, 71106
Douglas G. Stein, MD, PA
Tampa, Florida, 33613
About this study
Official title: The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm.
Ninety subjects from two centers in the United Stated will be followed closely for 24 months.
If you are someone interested in a vasectomy, you may be eligible to participate in this clinical study.
Read the detailed description
This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device (IVD) necessary to support the design of a future pivotal study. The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy.
- Conditions
- Male Sterilization
- Being tested
- Intra Vas Device (IVD)
- Keywords
- Male Contraceptive Devices, Intra Vas Device (IVD), Male Sterilization, Vasectomy, Intra Vas Deferens Occlusion, Vas Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra Vas Device (IVD)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.
The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.
IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery
techniques or Fascial Interposition require. One major advantage of the IVD is that it
does not require excision and removal of a portion of the vas. Implantation of the IVD
allows the vas deferens to remain intact and not be permanently damaged.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2006 (estimated)
- Study startSep 2006
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male SterilizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Shepherd Medical Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00335361
- Sponsor's protocol ID
- G050215
- Other IDs
- NIH grant # R44HD046318
- Status last verified
- Apr 2007
- First submitted
- 7 Jun 2006
- Last updated
- 6 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intra Vas Device (IVD) As A Means of Male Reproductive Sterilization A Single Armed Feasibility Study
- ClinicalTrials.gov ID
- NCT00335361
- Acronym / sponsor ID
- G050215
- Conditions
- Male Sterilization
- Keywords
- Male Contraceptive Devices, Intra Vas Device (IVD), Male Sterilization, Vasectomy, Intra Vas Deferens Occlusion, Vas Occlusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Shepherd Medical CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Sep 2009 (estimated)
- First posted
- 9 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is to evaluate a device for male reproductive sterilization and determine if this device is successful at blocking the sperm.
Ninety subjects from two centers in the United Stated will be followed closely for 24 months.
If you are someone interested in a vasectomy, you may be eligible to participate in this clinical study.
Detailed description
This feasibility study is intended to collect pertinent clinical information on the use of the Shepherd Medical Intra Vas Device (IVD) necessary to support the design of a future pivotal study. The IVD is intended to occlude the vas deferens and thus accomplish male reproductive sterilization and to offer an additional method to vasectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subject desires to undergo a vasectomy.
- Freely consents to participate in the Study a
- Agrees to provide a semen sample at regularized periods for at least 30 months.
- Willing to use a redundant method of contraception until successful occlusion is confirmed.
- Agrees to provide follow-up information.
Key exclusion criteria (4 listed)
- Has a condition permanently or temporarily making participation in the Study inadvisable.
- Has a condition permanently or temporarily making a vasectomy inadvisable.
- Has had a previous successful/unsuccessful vasectomy.
- Has had an allergic reaction to silicone and/or ethylene.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra Vas Device (IVD) | Device | – |
Primary outcome
Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.
The IVD consists of a tubular silicone plug that is inserted into the lumen of the vas deferens to block the flow of semen.
IVD implantation does not require the need to sever or permanently damage the vas deferens like the Ligation/Excision, Clip devices, Cautery
techniques or Fascial Interposition require. One major advantage of the IVD is that it
does not require excision and removal of a portion of the vas. Implantation of the IVD
allows the vas deferens to remain intact and not be permanently damaged.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intra Vas Device (IVD) in people with Male Sterilization, run by Shepherd Medical Company at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful IVD implantation with vas deferens occlusion at 6 and 24 months post-implant.. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2007.