Safety and Efficacy Study of Pain Shield Device to Treat... | NCT00737425

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

NCT00737425

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

Oct 28, 2008Estimated

Enrollment

80Estimated

Phase

Phase 4

Conditions

Wounds

Interventions

PainShield
Sham PainShield

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 17, 2008

First Submission Date that Met QC Criteria

Aug 18, 2008

First Posted Date

Aug 19, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2008

Last Update Posted Date

Oct 28, 2008Estimated

Name	Class
Nanovibronix	INDUSTRY

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Label	Type	Description	Intervention Names
1	Active Comparator		Device: PainShield
2	Sham Comparator		Device: Sham PainShield

Name	Type	Description	Arm Group Labels	Other Names
PainShield	Device		1
Sham PainShield

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain and discomfort will be measured using appropriate validated questionnaires.		Pain assessment will be performed daily

Secondary Outcomes

Measure	Description	Time Frame
Infections will be assessed by concomitant antibiotic intake		Concomitant medications will be assessed daily

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Petachia Reissman, MD	Contact	+972 2 6666310
Eran Lavi, MD	Contact	+972 2 6666310

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center	Recruiting	Jerusalem			Israel

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided