Evaluation of Safety and Efficacy of Using Seraffix LTB -... | NCT00521755

Studies
Evaluation of Safety and Efficacy of Using Seraffix LTB - (Laser Tissue Bonding) System

NCT00521755

Sponsor

Seraffix

Status

Completed

Last Update Posted

Jun 9, 2011Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Dehiscence, Surgical Wound

Interventions

Seraffix LTB

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Aug 26, 2007

First Submission Date that Met QC Criteria

Aug 26, 2007

First Posted Date

Aug 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2011

Last Update Posted Date

Jun 9, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of using Seraffix LTB system for soft tissue bonding.

Detailed Description

Dermatologic wounds can be closed by a variety of methods. The choice of a particular closure technique should be based on the patient, wound, tissue characteristics, and anatomic location. The purpose of these closure methods is an approximation of wound lips until the regenerate tissue reach a phase, where it is closed and can sustain the daily tensile forces.

Several methods are used for wounds closure such as sutures, staples, tapes, tissue adhesives and laser energy. There have been two fundamental approaches to laser assisted bonding of tissues:

Laser welding-heating the approximated edges of cuts in tissues by a laser beam;
Laser soldering- applying a biological solder onto the approximated edges and heating the solder (and the underlying tissue).

Seraffix has developed the Seraffix LTB (Laser Tissue Bonding) System - a laser system for soft tissue bonding. This innovative system includes features that make laser soldering suitable for clinical use. The Seraffix system is composed of CO2 laser device, propriety grip device (Clamps) and soldering agent (Human Albumin).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Label	Type	Description	Intervention Names
A	Experimental		Device: Seraffix LTB

Name	Type	Description	Arm Group Labels	Other Names
Seraffix LTB	Device	laser soldering for soft tissue wounds	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Subject objects to the study protocol.
Known cognitive or psychiatric disorder
Concurrent participation in any other clinical study.
Physician objection.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ossama Hatoum, Dr.	HaEmek Medical Center, Israel	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D013529	Surgical Wound Dehiscence

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

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Browse Branches

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