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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2008 by Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00737425
First Posted: August 19, 2008
Last Update Posted: October 28, 2008
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.
Collaborator:
Nanovibronix
Information provided by:
Shaare Zedek Medical Center
  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
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

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 ]

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

Estimated Enrollment: 80
Study Start Date: September 2008
Arms Assigned Interventions
Active Comparator: 1 Device: PainShield
Sham Comparator: 2 Device: Sham PainShield

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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

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
First Submitted: August 17, 2008
First Posted: August 19, 2008
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