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
  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
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, see Learn About Clinical Studies.

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 August 18, 2014