Primary Inguinal HerniaNCT01984996
Freedom Inguinal Hernia Repair System Study
A study testing Freedom ProFlor Inguinal Hernia Implant in people with Primary Inguinal Hernia, run by Insightra Medical, Inc. at 8 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals. The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Inguinal Hernia
- What is being tested?
- Freedom ProFlor Inguinal Hernia Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Dec 2013to Dec 2017
- 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
- Scheduled to undergo routine inguinal hernia repair
- Competent to give consent
- Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- Primary hernia at the operative site
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- Male or female
- Life expectancy of at least 12 months
- At least 18 years of age
Who cannot join
- Signs of obvious local or systemic infection
- Any previous surgery on the hernia operative site
- Hernia is not in the inguinal area
- Hernia is not identified as indirect or direct
- Femoral hernias
- Known collagen disorder
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- Presenting with unstable angina or NYHA class of IV
- Known Pregnancy
- Active drug user
- Recurrence of a repair by any method
- Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
- Immunosuppression, prednisone>15 mg/day, active chemotherapy
- End stage renal disease
- Abdominal ascites
- Skin infection in area of surgical field
- BMI >35
- Peritoneum cannot be closed
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States4 sites
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, 70808
Witham Health Services
Lebanon, Indiana, 46052
Metabolic Clinic and Research Center
Los Angeles, California, 90033
New Hannover Regional Medical Center
Wilmington, North Carolina, 28401
Italy3 sites
Istituto Clinico Sant'Ambrogio
Milan, 20149
Azienda Policlinico Umberto I
Roma, 00161
Policlinico Tor Vergata
Roma, 00161
About this study
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.
The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.
- Conditions
- Primary Inguinal Hernia
- Being tested
- Freedom ProFlor Inguinal Hernia Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freedom ProFlor Inguinal Hernia ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Freedom ProFlor Inguinal Hernia Implant | Experimental | Not described Receives: Device: Freedom ProFlor Inguinal Hernia Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
Measure quality of life for patients undergoing inguinal hernia repair.
Measured: 1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Secondary outcomes (1)
Evaluate the 14-day pain and medication log
Patient will record pain score and medications for 14 consecutive days.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017 (estimated)
Why it stopped: Company was dissolved.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insightra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl LeBlanc, M.D., M.B.A., F.A.C.S., Principal investigator, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01984996
- Sponsor's protocol ID
- P0069
- Status last verified
- Jan 2016
- First submitted
- 4 Nov 2013
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freedom Inguinal Hernia Repair System Study
- ClinicalTrials.gov ID
- NCT01984996
- Acronym / sponsor ID
- P0069
- Conditions
- Primary Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company was dissolved.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Insightra Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (estimated)
- First posted
- 15 Nov 2013 (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.
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.
The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Freedom ProFlor Inguinal Hernia Implant | Experimental | Device: Freedom ProFlor Inguinal Hernia Implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Scheduled to undergo routine inguinal hernia repair
- Competent to give consent
- Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
Key exclusion criteria (17 listed)
- Signs of obvious local or systemic infection
- Any previous surgery on the hernia operative site
- Hernia is not in the inguinal area
- Hernia is not identified as indirect or direct
- Femoral hernias
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 |
|---|---|---|
| Freedom ProFlor Inguinal Hernia Implant | Device | Freedom ProFlor Inguinal Hernia Implant |
Primary outcome
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
Time frame: 1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Measure quality of life for patients undergoing inguinal hernia repair.
1 secondary outcome
Evaluate the 14-day pain and medication log
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Company was dissolved.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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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.
Karl LeBlanc, M.D., M.B.A., F.A.C.S. principal investigator
Our Lady of the Lake Hospital
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freedom ProFlor Inguinal Hernia Implant in people with Primary Inguinal Hernia, run by Insightra Medical, Inc. at 8 sites in 3 countries.
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 9 inclusion and 17 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 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Italy, Austria. 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: Company was dissolved.). 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?
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals (time frame: 1 week, 3, 6, 9, 12, 18, 24, and 36 months.). 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 9 Jun 2016.