Status:
UNKNOWN
Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
Lead Sponsor:
Shaare Zedek Medical Center
Collaborating Sponsors:
Nanovibronix
Conditions:
Wounds
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 abd...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00737425
Start Date
September 1 2008
Last Update
October 28 2008
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel