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NCT00737425 Clinical Trial

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

Wounds Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00737425
Other study ID # NV-PS-02-001
Secondary ID
Status Recruiting
Phase Phase 4
First received August 17, 2008
Last updated October 27, 2008
Start date September 2008

Study information
Verified date October 2008
Source Shaare Zedek Medical Center
Contact Petachia Reissman, MD
Phone +972 2 6666310
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• PainShield

• Sham PainShield

Locations
Country Name City State
Israel Shaare Zedek Medical Center Jerusalem

Sponsors (2)
Lead Sponsor Collaborator
Shaare Zedek Medical Center Nanovibronix

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain and discomfort will be measured using appropriate validated questionnaires. Pain assessment will be performed daily No
Secondary Infections will be assessed by concomitant antibiotic intake Concomitant medications will be assessed daily No
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