Inguinal HerniaNCT00423241
SEMPERFLO* Pain Management System in Inguinal Hernia Repair
A study testing SEMPERFLO Pain Management System and ON-Q PainBuster Post-Op Pain Relief System in people with Inguinal Hernia and Pain, run by Ethicon, Inc. at 6 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Pain
- What is being tested?
- SEMPERFLO Pain Management System and ON-Q PainBuster Post-Op Pain Relief System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Boca Raton Community Hospital
Boca Raton, Florida
North Texas Surgery Center
Dallas, Texas
Michale E. DeBakey VA Medical Center
Houston, Texas
Jacksonville Center for Clinical Research
Jacksonville, Florida
Universtiy of Tennessee
Knoxville, Tennessee
Washington University
St Louis, Missouri
About this study
Official title: A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair
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
Read the detailed description
Pain will be evaluated up to 5 days after surgery Subjects will be followed for 30 days after surgery.
- Conditions
- Inguinal Hernia, Pain
- Being tested
- SEMPERFLO Pain Management System, ON-Q PainBuster Post-Op Pain Relief System
- Medical subject headings
- Hernia, Inguinal, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEMPERFLO Pain Management SystemDevice
Also called Pain management system
continuous infusion of 0.5% bupivacaine at 2mL per hour
ON-Q PainBuster Post-Op Pain Relief SystemDevice
Also called Pain management system
continuous infusion of 0.5% bupivacaine at 2mL per hour
| Study group | Role | What they receive |
|---|---|---|
| SEMPERFLO Pain Management System | Experimental | Not described Receives: Device: SEMPERFLO Pain Management System |
| ON-Q PainBuster Post-Op Pain Relief System | Active comparator | Not described Receives: Device: ON-Q PainBuster Post-Op Pain Relief System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Measured: twenty-four hours post procedure
Secondary outcomes (2)
Narcotic and non-narcotic analgesic usage
Measured: 24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing
Measured: 24, 48, 72, 96, and 120 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2007
- Study completionJan 2008
Why it stopped: Market dynamics including other technologies made the project not viable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ethicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Martin Weisberg, MD, Study director, Ethicon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423241
- Sponsor's protocol ID
- 200-06-004
- Status last verified
- Aug 2010
- First submitted
- 16 Jan 2007
- Last updated
- 23 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Exploratory Comparison of the SEMPERFLO* Pain Management System to a Commercially Available Pain Relief System in Subjects Undergoing Open Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT00423241
- Acronym / sponsor ID
- 200-06-004
- Conditions
- Inguinal Hernia, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Market dynamics including other technologies made the project not viable.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Ethicon, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SEMPERFLO Pain Management SystemAlso: Pain management systemcontinuous infusion of 0.5% bupivacaine at 2mL per hour | Device | SEMPERFLO Pain Management System |
| ON-Q PainBuster Post-Op Pain Relief SystemAlso: Pain management systemcontinuous infusion of 0.5% bupivacaine at 2mL per hour | Device | ON-Q PainBuster Post-Op Pain Relief System |
Primary outcome
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale
Time frame: twenty-four hours post procedure
2 secondary outcomes
Narcotic and non-narcotic analgesic usage
Time frame: 24, 48, 72, 96 and 120 hours post- procedure
Numeric pain scale scores at rest and with coughing
Time frame: 24, 48, 72, 96, and 120 hours post-procedure
Results and safety
The study was stopped early (reason given: Market dynamics including other technologies made the project not viable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Weisberg, MD study director
Ethicon, Inc.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SEMPERFLO Pain Management System and ON-Q PainBuster Post-Op Pain Relief System in people with Inguinal Hernia and Pain, run by Ethicon, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Market dynamics including other technologies made the project not viable.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic pain (pain measured with coughing) measured using a ten-point visual analog scale (time frame: twenty-four hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2010.