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
Sponsor:
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

August 17, 2008
October 27, 2008
September 2008
Not Provided
Pain and discomfort will be measured using appropriate validated questionnaires. [ Time Frame: Pain assessment will be performed daily ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00737425 on ClinicalTrials.gov Archive Site
Infections will be assessed by concomitant antibiotic intake [ Time Frame: Concomitant medications will be assessed daily ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Wounds
  • Device: PainShield
  • Device: Sham PainShield
  • Active Comparator: 1
    Intervention: Device: PainShield
  • Sham Comparator: 2
    Intervention: Device: Sham PainShield
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact: Petachia Reissman, MD +972 2 6666310
Contact: Eran Lavi, MD +972 2 6666310
Israel
 
NCT00737425
NV-PS-02-001
Not Provided
Prof Petachia Reissman, Head of Surgery Department, Shaare Zedek Medical Center, Jerusalem, Israel
Shaare Zedek Medical Center
Nanovibronix
Not Provided
Shaare Zedek Medical Center
October 2008

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