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Evaluation of the BioWeld1 System as a Method for Surgical Incision Closure

NCT01709240 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2015-03-27

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and performance of the BioWeld1 System procedure for surgical incision closure of the skin in women scheduled for elective C-section procedure.

Conditions

  • Child Delivery Using an Elective C- Section

Interventions

DEVICE

BioWeld1 System

External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.

Sponsors & Collaborators

  • IonMed Ltd

    lead INDUSTRY

Principal Investigators

  • Drorit Hochner-Celnikier, MD · Hadassah University Hospital, Mount Scopus

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-04-30
Completion
2014-04-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709240 on ClinicalTrials.gov