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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00737425
Recruitment Status : Unknown
Verified October 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : August 19, 2008
Last Update Posted : October 28, 2008
Sponsor:
Collaborator:
Nanovibronix
Information provided by:
Shaare Zedek Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wounds Device: PainShield Device: Sham PainShield Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : September 2008
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 1 Device: PainShield
Sham Comparator: 2 Device: Sham PainShield


Outcome Measures
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Primary Outcome Measures :
  1. Pain and discomfort will be measured using appropriate validated questionnaires. [ Time Frame: Pain assessment will be performed daily ]

Secondary Outcome Measures :
  1. Infections will be assessed by concomitant antibiotic intake [ Time Frame: Concomitant medications will be assessed daily ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00737425


Contacts
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Contact: Petachia Reissman, MD +972 2 6666310
Contact: Eran Lavi, MD +972 2 6666310

Locations
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Israel
Shaare Zedek Medical Center Recruiting
Jerusalem, Israel
Sponsors and Collaborators
Shaare Zedek Medical Center
Nanovibronix
More Information
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Responsible Party: Prof Petachia Reissman, Head of Surgery Department, Shaare Zedek Medical Center, Jerusalem, Israel
ClinicalTrials.gov Identifier: NCT00737425    
Other Study ID Numbers: NV-PS-02-001
First Posted: August 19, 2008    Key Record Dates
Last Update Posted: October 28, 2008
Last Verified: October 2008
Keywords provided by Shaare Zedek Medical Center:
laparoscopic-assisted surgery
abdominal
pain relief
wound healing
low intensity ultrasound