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

NCT ID: NCT00737425

Last Updated: 2008-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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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

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Conditions

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Wounds

Keywords

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laparoscopic-assisted surgery abdominal pain relief wound healing low intensity ultrasound

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Group Type ACTIVE_COMPARATOR

PainShield

Intervention Type DEVICE

2

Group Type SHAM_COMPARATOR

Sham PainShield

Intervention Type DEVICE

Interventions

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PainShield

Intervention Type DEVICE

Sham PainShield

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanovibronix

INDUSTRY

Sponsor Role collaborator

Shaare Zedek Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Shaare Zedek Medical Center, Jerusalem, Israel

Locations

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Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Petachia Reissman, MD

Role: CONTACT

Phone: +972 2 6666310

Eran Lavi, MD

Role: CONTACT

Phone: +972 2 6666310

Other Identifiers

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NV-PS-02-001

Identifier Type: -

Identifier Source: org_study_id