Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery

Shaare Zedek Medical Center1 site in 1 country80 target enrollmentSeptember 2008

ConditionsWounds

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Wounds
Sponsor: Shaare Zedek Medical Center
Enrollment: 80
Locations: 1
Primary Endpoint: Pain and discomfort will be measured using appropriate validated questionnaires.
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate safety and efficacy of PainShield device, based on ultrasound technology, for postoperative pain relief and wound healing following a laparoscopic-assisted abdominal surgery.

Registry

clinicaltrials.gov

Start Date

September 2008

End Date

TBD

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shaare Zedek Medical Center

Eligibility Criteria

Inclusion Criteria

•Subject's Age ≥ 18
•Subject is able, agrees and signs the Informed Consent Form
•Subject requires laparoscopic-assisted abdominal surgery
•Incision size following the laparoscopy between 4-7 cm

Exclusion Criteria

•Epidural analgesia
•Subject has any condition, which precludes compliance with study and/or device instructions
•Subject is currently participating in another clinical study.