NCT02149979

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of using Temperature Controlled Laser Soldering System for soft tissue bonding.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

May 25, 2014

Last Update Submit

May 28, 2014

Conditions

Wound

Keywords

IncisionWound ClosureLaser Tissue Soldering

Outcome Measures

Primary Outcomes (1)

  • Primary study endpoint will be to establish the safety of using the Temperature Controlled Laser Soldering System for skin bonding and wounds closure. Safety will be established by paucity of serious adverse events and adverse events.

    3 months

Secondary Outcomes (2)

  • 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).

    3 months

  • Wound dehiscence of at least 50% of wound length

    3 months

Study Arms (1)

Temperature Controlled Laser Soldering

EXPERIMENTAL

Efficacy and safety of Temperature Controlled Laser Soldered wound incisions closure

Device: Temperature Controlled Laser Soldering

Interventions

Temperature Controlled Laser SolderingDEVICE

This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.

Temperature Controlled Laser Soldering

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male/Female age 18-65.
  • Subject is scheduled for laparoscopic cholecystectomy surgery.
  • Subject able to comprehend and sign informed consent for participation in this study.
  • Ability to comply with the study procedures and follow-up visits

You may not qualify if:

  • Subject has a history of hypertrophic or keloid scar formation
  • Subject is a pregnant and/or nursing woman
  • Subject has a known allergy to blood products
  • Subject is suffering from a bleeding disorders or using anticoagulant medications
  • Subject is suffering from hepatic or renal disorder
  • Subject is suffering from rheumatic and / or collagen disorder
  • Subject is using steroids
  • Subject is suffering from immunosuppressive disorder
  • Subject is suffering from Ischemic Heart Disease (IHD)
  • Subject is suffering from neoplastic disorder
  • Subject who has had an active illness within 4 weeks of study enrollment
  • Subject is participating in another study for an investigational drug and/or device within 3 months of study enrollment
  • Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery B, "HaEmek" Medical Center

Afula, 18341, Israel

Location

Haemek Medical Center

Afula, 18341, Israel

Location

Related Publications (4)

  • Simhon D, Halpern M, Brosh T, Vasilyev T, Ravid A, Tennenbaum T, Nevo Z, Katzir A. Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin. Ann Surg. 2007 Feb;245(2):206-13. doi: 10.1097/01.sla.0000232554.13719.10.

    PMID: 17245173BACKGROUND

  • Simhon D, Brosh T, Halpern M, Ravid A, Vasilyev T, Kariv N, Katzir A, Nevo Z. Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern. Lasers Surg Med. 2004;35(1):1-11. doi: 10.1002/lsm.20074.

    PMID: 15278922BACKGROUND

  • Brosh T, Simhon D, Halpern M, Ravid A, Vasilyev T, Kariv N, Nevo Z, Katzir A. Closure of skin incisions in rabbits by laser soldering II: Tensile strength. Lasers Surg Med. 2004;35(1):12-7. doi: 10.1002/lsm.20073.

    PMID: 15278923BACKGROUND

  • Simhon D, Ravid A, Halpern M, Cilesiz I, Brosh T, Kariv N, Leviav A, Katzir A. Laser soldering of rat skin, using fiberoptic temperature controlled system. Lasers Surg Med. 2001;29(3):265-73. doi: 10.1002/lsm.1118.

    PMID: 11573230BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesSurgical Wound

Study Officials

  • Doron Kopelman, MD

    Department of Surgery B, "HaEmek" Medical Center, Afula,

    PRINCIPAL INVESTIGATOR

  • Abraham Katzir, PhD

    The applied physics group, Tel Aviv University

    STUDY CHAIR

  • David Simhon, MD, PhD

    The applied physics group, Tel Aviv University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of the applied physics group

Study Record Dates

First Submitted

May 25, 2014

First Posted

May 29, 2014

Study Start

March 1, 2007

Primary Completion

January 1, 2008

Study Completion

January 1, 2009

Last Updated

May 29, 2014

Record last verified: 2014-05

Locations

IL(2)