Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Shaare Zedek Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Shaare Zedek Medical Center
Collaborator:
Nanovibronix
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00737425
First received: August 17, 2008
Last updated: October 27, 2008
Last verified: October 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Wounds |
Device: PainShield Device: Sham PainShield |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery |
Further study details as provided by Shaare Zedek Medical Center:
Primary Outcome Measures:
- Pain and discomfort will be measured using appropriate validated questionnaires. [ Time Frame: Pain assessment will be performed daily ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Infections will be assessed by concomitant antibiotic intake [ Time Frame: Concomitant medications will be assessed daily ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | September 2008 |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 | Device: PainShield |
| Sham Comparator: 2 | Device: Sham PainShield |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00737425
Contacts
| Contact: Petachia Reissman, MD | +972 2 6666310 | |
| Contact: Eran Lavi, MD | +972 2 6666310 |
Locations
| Israel | |
| Shaare Zedek Medical Center | Recruiting |
| Jerusalem, Israel | |
Sponsors and Collaborators
Shaare Zedek Medical Center
Nanovibronix
More Information
No publications provided
| Responsible Party: | Prof Petachia Reissman, Head of Surgery Department, Shaare Zedek Medical Center, Jerusalem, Israel |
| ClinicalTrials.gov Identifier: | NCT00737425 History of Changes |
| Other Study ID Numbers: | NV-PS-02-001 |
| Study First Received: | August 17, 2008 |
| Last Updated: | October 27, 2008 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Shaare Zedek Medical Center:
|
laparoscopic-assisted surgery abdominal pain relief wound healing low intensity ultrasound |
ClinicalTrials.gov processed this record on May 23, 2013