AdhesionsPhase 2NCT00116233
Pediatric Multicenter Study of REPEL-CV
A Phase 2 study testing REPEL-CV in people with Adhesions, run by SyntheMed at 1 site in United States.
Trial summary
This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery. Read more about this study
- Who is it for?
- Ages 1 day to 1 year
- Conditions the study is for
- Adhesions
- What is being tested?
- REPEL-CV
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 1 day to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Stage sternotomies
Who cannot join
- Delayed closure beyond 5 days
Trial locations and contacts
1 site in 1 country.
Eli Pines, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
SyntheMed
Little Silver, New Jersey, 07739
Eli Pines, Ph.D., 212-460-9488
About this study
Official title: Peds. Multicenter Study
This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.
Read the detailed description
- Efficacy at second sternotomy
- Conditions
- Adhesions
- Being tested
- REPEL-CV
- Keywords
- post operative adhesions
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REPEL-CVDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- SyntheMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eli Pines, Study director, SyntheMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00116233
- Sponsor's protocol ID
- LMS0104RCV
- Status last verified
- Jun 2005
- First submitted
- 27 Jun 2005
- Last updated
- 28 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peds. Multicenter Study
- ClinicalTrials.gov ID
- NCT00116233
- Acronym / sponsor ID
- LMS0104RCV
- Conditions
- Adhesions
- Keywords
- post operative adhesions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- SyntheMedIndustry (pharma, biotech, devices)
- First posted
- 28 Jun 2005 (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.
This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.
Detailed description
- Efficacy at second sternotomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 1 day to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Stage sternotomies
Key exclusion criteria (1 listed)
- Delayed closure beyond 5 days
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 |
|---|---|---|
| REPEL-CV | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2005.
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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.
Eli Pines, Ph.D. contact
Eli Pines study director
SyntheMed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing REPEL-CV in people with Adhesions, run by SyntheMed at 1 site 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 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 28 Jun 2005. 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Eli Pines, Ph.D. (212-460-9488), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 28 Jun 2005.