Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery

Phase 4

• Conditions: Wounds
• Interventions: Device: PainShield; Device: Sham PainShield

• Registration Number: NCT00737425
• Lead Sponsor: Shaare Zedek Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-17
• Study First Submitted QC: 2008-08-18
• Study First Posted: 2008-08-19
• Study Start: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-27
• Last Update Posted: 2008-10-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PainShield	-
2	Sham PainShield	-

Primary Outcome Measures

Name	Time	Method
Pain and discomfort will be measured using appropriate validated questionnaires.	Pain assessment will be performed daily

Secondary Outcome Measures

Name	Time	Method
Infections will be assessed by concomitant antibiotic intake	Concomitant medications will be assessed daily

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel