Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2008
CompletedFirst Posted
Study publicly available on registry
August 19, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedOctober 28, 2008
October 1, 2008
August 17, 2008
October 27, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain and discomfort will be measured using appropriate validated questionnaires.
Pain assessment will be performed daily
Secondary Outcomes (1)
Infections will be assessed by concomitant antibiotic intake
Concomitant medications will be assessed daily
Study Arms (2)
1
ACTIVE COMPARATOR2
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shaare Zedek Medical Centerlead
- Nanovibronixcollaborator
Study Sites (1)
Shaare Zedek Medical Center
Jerusalem, Israel
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 17, 2008
First Posted
August 19, 2008
Study Start
September 1, 2008
Last Updated
October 28, 2008
Record last verified: 2008-10