SEMPERFLO* Pain Management System in Inguinal Hernia Repair | NCT00423241

Studies
SEMPERFLO* Pain Management System in Inguinal Hernia Repair

NCT00423241

Sponsor

Ethicon, Inc.

Status

Terminated

Last Update Posted

Aug 23, 2010Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Inguinal Hernia
Pain

Interventions

SEMPERFLO Pain Management System
ON-Q PainBuster Post-Op Pain Relief System

Countries

United States

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

Aug 2010

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Market dynamics including other technologies made the project not viable.

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2007Actual

Completion Date

Jan 2008Actual

First Submitted Date

Jan 16, 2007

First Submission Date that Met QC Criteria

Jan 17, 2007

First Posted Date

Jan 18, 2007Estimated

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

Aug 20, 2010

Last Update Posted Date

Aug 23, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will compare the clinical performance of the SEMPERFLO* Pain Management System with another commercial pain relief system using 0.5% bupivacaine following unilateral, open, inguinal hernia repair procedures.

*Trademark

Detailed Description

Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SEMPERFLO Pain Management System	Experimental		Device: SEMPERFLO Pain Management System
ON-Q PainBuster Post-Op Pain Relief System	Active Comparator		Device: ON-Q PainBuster Post-Op Pain Relief System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SEMPERFLO Pain Management System	Device	continuous infusion of 0.5% bupivacaine at 2mL per hour	SEMPERFLO Pain Management System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale		twenty-four hours post procedure

Secondary Outcomes

Measure	Description	Time Frame
Narcotic and non-narcotic analgesic usage		24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing		24, 48, 72, 96, and 120 hours post-procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is a candidate for primary, non-emergent unilateral, open inguinal hernia repair procedure
Subject is 18 years or older
Subject must be willing to participate in the study, and provide informed consent to participate.

Exclusion Criteria:

Subjects undergoing recurrent hernia repair;
Subjects who plan to undergo another elective surgical procedure prior to the completion of this study;
Subjects with known allergy to bupivacaine;
Subjects with immunodeficiency diseases (including known HIV);
Subjects with any findings identified by the surgeon that may preclude conduct of the study;
Subjects who are known current alcohol and/or drug abusers;

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

Not provided

Overall Officials

Name	Affiliation	Role
Martin Weisberg, MD	Ethicon, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boca Raton Community Hospital		Boca Raton	Florida		United States
Jacksonville Center for Clinical Research

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal
D010146	Pain

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided