NCT00737425UnknownPhase 4
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 enrollmentStarted: September 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Shaare Zedek Medical Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Pain and discomfort will be measured using appropriate validated questionnaires.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
1
Active Comparator
Intervention: PainShield (Device)
2
Sham Comparator
Intervention: Sham PainShield (Device)
Outcomes
Primary Outcomes
Pain and discomfort will be measured using appropriate validated questionnaires.
Time Frame: Pain assessment will be performed daily
Secondary Outcomes
- Infections will be assessed by concomitant antibiotic intake(Concomitant medications will be assessed daily)
Investigators
Study Sites (1)
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