WoundsPhase 1NCT01069614
A Skin Stretching Wound Closure System
A Phase 1 study testing TopClosure 3S System in people with Wounds and Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- TopClosure 3S System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hard to close wounds
Who cannot join
- Non-cooperative patients
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Moris Topaz, MD, PhD, 972-4-630-4689, mtopazmd@yahoo.com
About this study
A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.
- Being tested
- TopClosure 3S System
- Keywords
- Equipment and supplies
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopClosure 3S SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| Skin stretching device | Experimental | Skin stretching device Receives: Device: TopClosure 3S System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of wound closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01069614
- Sponsor's protocol ID
- HYMC-09
- Status last verified
- Feb 2010
- First submitted
- 7 Feb 2010
- Last updated
- 17 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Skin Stretching Wound Closure System
- ClinicalTrials.gov ID
- NCT01069614
- Acronym / sponsor ID
- HYMC-09
- Keywords
- Equipment and supplies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- First posted
- 17 Feb 2010 (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.
A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin stretching device | Experimental | Device: TopClosure 3S SystemSkin stretching device |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hard to close wounds
Key exclusion criteria (1 listed)
- Non-cooperative patients
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 |
|---|---|---|
| TopClosure 3S System | Device | Skin stretching device |
Primary outcome
Safety and efficacy of wound closure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TopClosure 3S System in people with Wounds and Injuries, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and efficacy of wound closure. 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 17 Feb 2010.