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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01069614
Other study ID # HYMC-09
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received February 7, 2010
Last updated February 16, 2010

Study information

Verified date February 2010
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

A skin stretching device has been designed to stretch tissue prior to surgery, during surgery and in order to secure wounds following surgery. The device may be used in non-invasive and invasive applications.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Hard to close wounds

Exclusion Criteria:

- Non-cooperative patients

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
TopClosure 3S System


Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and efficacy of wound closure Yes
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