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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

Tracking Information
First Submitted Date  ICMJE August 17, 2008
First Posted Date  ICMJE August 19, 2008
Last Update Posted Date October 28, 2008
Study Start Date  ICMJE September 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Pain and discomfort will be measured using appropriate validated questionnaires. [ Time Frame: Pain assessment will be performed daily ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Infections will be assessed by concomitant antibiotic intake [ Time Frame: Concomitant medications will be assessed daily ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Pain Shield Device to Treat Subjects Following Laparoscopic-Assisted Abdominal Surgery
Official Title  ICMJE Evaluation of Safety and Efficacy of the PainShield Device for the Treatment of Subjects Who Underwent Laparoscopic-Assisted Abdominal Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Wounds
Intervention  ICMJE
  • Device: PainShield
  • Device: Sham PainShield
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Device: PainShield
  • Sham Comparator: 2
    Intervention: Device: Sham PainShield
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 18, 2008)
80
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00737425
Other Study ID Numbers  ICMJE NV-PS-02-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Petachia Reissman, Head of Surgery Department, Shaare Zedek Medical Center, Jerusalem, Israel
Study Sponsor  ICMJE Shaare Zedek Medical Center
Collaborators  ICMJE Nanovibronix
Investigators  ICMJE Not Provided
PRS Account Shaare Zedek Medical Center
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP