Study to Evaluate the Safety and Efficacy of Dermal Injections of JVS-100 Given to Adults Receiving Median Sternotomy
Public ClinicalTrials.gov record NCT01657045. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I Randomized, Double-Blind, Placebo Controlled Dose Escalation Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Needle-free Dermal Injection to Cohorts of Adults Receiving Surgical Sternotomy Incisions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will investigate the safety and efficacy of using JVS-100 to accelerate wound healing and reduce scar formation in subjects receiving surgical incisions ("sternotomies") during cardiovascular surgery. Twenty-five (25) subjects receiving a median sternotomy of 16 - 25 cm in the process of cardiothoracic surgery will be enrolled consecutively and be followed for 6 months post-dosing. Three cohorts of approximately 8 subjects each will be enrolled, and within each cohort subjects will be randomized 3:1 to receive a single set of needle-free dermal injections of either JVS-100 or placebo. JVS-100 or placebo will be delivered along the edge of the sternal wound using a needle-free injection device that has FDA-clearance for subcutaneous injections.
Study identification
- NCT ID
- NCT01657045
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2012
- Primary completion
- Nov 30, 2013
- Completion
- Jun 30, 2014
- Last update posted
- Jul 22, 2013
2012 – 2014
United States locations
- U.S. sites
- 6
- U.S. states
- 6
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pepin Heart Institute | Tampa | Florida | 33613 | Recruiting |
| Northwestern University Bluhm Cardiovascular Inst | Chicago | Illinois | 60611 | Recruiting |
| Montefiore Medical Center | New York | New York | 10467 | Recruiting |
| Summa Health System Hospital | Akron | Ohio | 44304 | Recruiting |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | Recruiting |
| Sentara Cardiovascular Research Institute | Norfolk | Virginia | 23507 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01657045, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 22, 2013 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01657045 live on ClinicalTrials.gov.