Inguinal HerniaNCT02240550
A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
A study testing ProFlor Hernia Repair System and Lichtenstein hernia repair in people with Inguinal Hernia, run by Insightra Medical, Inc. at 1 site in India.
Trial summary
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- ProFlor Hernia Repair System and Lichtenstein hernia repair
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2014to Dec 2014
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo routine inguinal hernia repair
- Male and Female patients between 18 and 65 years old
- Competent to give consent
- Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
- Defect size at operation is between 5mm and 35mm
- Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- Primary hernia at the operative site
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
Show all 25Show fewer
- Presenting with unstable angina or NYHA class of IV
- Known Pregnancy or Nursing women
- 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
- Patient has a clinically relevant co-morbidity (antithrombic prophylaxis due to cardiovascular pathologies, diabetes requiring insulin therapy or immunodeficiency syndrome of any type)
- Neutropenia with absolute neutrophil count (ANC)<500 cells/mm3
- Significant of life-threatening condition (e.g., endocarditis) that would confound or interfere with the procedure
- Patients that require anticoagulant monitoring with an activated partial thromboplastin time (aPTT)
- Patients unwilling to forego blood and/or blood product donation for at least 3 months from initiation of first study device
- Treatment with investigational medicinal product within 30 days before enrollment and for the duration of the study
- Investigational device present, or removed within 30 days before enrollment, or presence of device-related infection
- Patients who the investigator considers unlikely to adhere to the protocol or complete the clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
This investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.
Read the detailed description
The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives.
The secondary objective of the study is to identify any short-term study related complications/adverse events.
The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone.
Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.
- Conditions
- Inguinal Hernia
- Being tested
- ProFlor Hernia Repair System, Lichtenstein hernia repair
- Keywords
- Open Inguinal Hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProFlor Hernia Repair SystemDevice
Also called 3D mesh
The 3-D hernia mesh will be used in the repair of your inguinal hernia.
Lichtenstein hernia repairDevice
Also called Polypropylene
The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
| Study group | Role | What they receive |
|---|---|---|
| ProFlor Hernia Repair System | Active comparator | A 3-D hernia mesh Receives: Device: ProFlor Hernia Repair System |
| Lichtenstein Hernia Repair | Active comparator | Using flat polypropylene mesh Receives: Device: Lichtenstein hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the immediate and short-term amount of pain.
We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
Measured: 1 month
Compare the time required for return to normal activities (work).
We will capture the time required to return to normal activities as indicated by the patient.
Measured: 1 month
Secondary outcomes (1)
Identify any short-term related complication/adverse events associated with the procedures.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insightra Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Murphy, MD, Principal investigator, Healing Hands Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02240550
- Sponsor's protocol ID
- P0133
- Status last verified
- Jan 2016
- First submitted
- 8 Sep 2014
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-armed, Single-blinded, Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT02240550
- Acronym / sponsor ID
- P0133
- Conditions
- Inguinal Hernia
- Keywords
- Open Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Insightra Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Sep 2014 (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 investigation will be a double-armed, randomized (Blinded patients and Blinded examiner) prospective study designed to collect perioperative and postoperative data to compare the QOL of ProFlor vs. Lichtenstein inguinal hernia repair.
Detailed description
The primary objectives of this study will be to evaluate the immediate and short-term amount of post-operative pain, the quality of life (QOL), as well as return to normal activities (work) for the two procedures. Carolinas Comfort Scale (CCS) and Visual Analogue Score (VAS) assessments will be held at regular intervals to evaluate these objectives.
The secondary objective of the study is to identify any short-term study related complications/adverse events.
The follow up will be immediately post-operative, post-operative day 1, and 1, 2,and 4 weeks. The first and 4th week's visits are mandatory office visits (if possible). If not available for office visit, a CCS assessment will be mailed or will be conducted via phone.
Up to 50 patients may be enrolled for this study (25 per arm). A report may be generated for presentation at an international meeting such as the AHS, EHS, or APHS if decided by the lead investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProFlor Hernia Repair System | Active comparator | Device: ProFlor Hernia Repair SystemA 3-D hernia mesh |
| Lichtenstein Hernia Repair | Active comparator | Device: Lichtenstein hernia repairUsing flat polypropylene mesh |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Scheduled to undergo routine inguinal hernia repair
- Male and Female patients between 18 and 65 years old
- Competent to give consent
- Clinically relevant inguinal hernia (classification: EHS P L/M 1/2/3)
- Defect size at operation is between 5mm and 35mm
Key exclusion criteria (25 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 |
|---|---|---|
| ProFlor Hernia Repair SystemAlso: 3D meshThe 3-D hernia mesh will be used in the repair of your inguinal hernia. | Device | ProFlor Hernia Repair System |
| Lichtenstein hernia repairAlso: PolypropyleneThe standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia. | Device | Lichtenstein Hernia Repair |
Primary outcome
Evaluate the immediate and short-term amount of pain.
Time frame: 1 month
We will evaluate the immediate and short-term amount of pain using the VAS and Carolinas Comfort Scale (CCS) assessments held at regular intervals.
Compare the time required for return to normal activities (work).
Time frame: 1 month
We will capture the time required to return to normal activities as indicated by the patient.
1 secondary outcome
Identify any short-term related complication/adverse events associated with the procedures.
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 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.
John Murphy, MD principal investigator
Healing Hands Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProFlor Hernia Repair System and Lichtenstein hernia repair in people with Inguinal Hernia, run by Insightra Medical, Inc. at 1 site in India.
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 7 inclusion and 25 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: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluate the immediate and short-term amount of pain. (time frame: 1 month). The study lists 2 primary outcomes in all. 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 18 Jan 2016.