Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System
1 other identifier
interventional
15
1 country
1
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2007
CompletedFirst Posted
Study publicly available on registry
August 28, 2007
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedJune 9, 2011
June 1, 2009
11 months
August 26, 2007
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary study endpoint will be to establish the safety of using the Seraffix System for tissue bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.
3 months
Secondary Outcomes (1)
1. Re-intervention: A subject is scored a success (1) if he had No Re-intervention by 3 months; otherwise he is scored a failure (0). 2. Wound dehiscence of at least 50% of wound length:
3 months
Study Arms (1)
A
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Male/Female age 18-60.
- Subject is scheduled for laparoscopic cholecystectomy surgery.
- Subject able to comprehend and give informed consent for participation in this study.
- Signed informed consent form.
You may not qualify if:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to screening.
- Acute infection requiring intravenous antibiotics at the time of screening.
- Bleeding, coagulation and or clotting disorders.
- Diabetes mellitus: IDDM or NIDDM.
- HIV positive or any other immunosuppressive disorder.
- Renal failure (Serum creatinine \>2.0 mg/dl).
- Inflammatory and or allergic diseases or condition of the skin: Psoriasis, Eczema or dermatitis.
- Any concomitant infection - viral or bacterial.
- Drug abuse.
- Use of steroids.
- Infection / abscess / pain in treatment target area.
- Pregnancy or lactating.
- History of keloid scarring.
- Use of aspirin or antioxidants
- Subject is suffering extreme general weakness.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seraffixlead
Study Sites (1)
Haemek Medical Center
Afula, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ossama Hatoum, Dr.
HaEmek Medical Center, Israel
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 26, 2007
First Posted
August 28, 2007
Study Start
December 1, 2008
Primary Completion
November 1, 2009
Study Completion
February 1, 2010
Last Updated
June 9, 2011
Record last verified: 2009-06