Hernia, InguinalPhase 4NCT01877122
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
A Phase 4 study testing Proflex® Mesh Mesh implantation and Marlex® Mesh Implant in people with Hernia, Inguinal, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
Trial summary
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up. Read more about this study
- Who is it for?
- Ages 20 to 85 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- Proflex® Mesh Mesh implantation and Marlex® Mesh Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 4
- 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 20 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients >=20 years =<85 years old
- Patients with Unilateral hernia
- Patients without previous operations in lower part of abdomen
- Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
- Patients capable to participate during the period of the trial
Who cannot join
- Previous hernia repair at the same site
- Incarcerated hernia
- Strangulated hernia
- Patients to whom and open surgery cannot be indicated
- Previous urological surgery
- Immune incompetence of patient: AIDS, vesical fibrosis, etc.
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- Patients with AIHD or patients who take immunosuppressive drugs
- Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
- Patients with kidney disease (creatinine>2.0mg/dL)
- Patients on anti-coagulants
- Patients with severe systematic disease
- Patients with malignant tumor
- Patients with infection or with the predicted problem of surgery site healing
- Participation in another clinical study within the last 30 days
- Patients whose participation is considered inappropriate according to other except above mentioned clinical condition
Trial locations and contacts
1 site in 1 country.
About this study
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
- Conditions
- Hernia, Inguinal
- Being tested
- Proflex® Mesh Mesh implantation, Marlex® Mesh Implant
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proflex® Mesh Mesh implantationDevice
Implantation of mesh in the incision of inguinal area
Marlex® Mesh ImplantDevice
| Study group | Role | What they receive |
|---|---|---|
| Proflex® Mesh | Experimental | Device: Partially absorbable lightweight mesh Intervention: Mesh implantation Receives: Device: Proflex® Mesh Mesh implantation |
| Marlex® Mesh | Active comparator | Device: Non-absorbable Heavyweight mesh Intervention: Mesh implantation Receives: Device: Marlex® Mesh Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score (10-point Visual Analogue Scale)
Measured: Day90 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startApr 2013
- Primary completionDec 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 Hernia, InguinalStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samyang Biopharmaceuticals Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Taeil Son, M.D., Ph.D., Principal investigator, Eulji Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877122
- Sponsor's protocol ID
- MS1-1004
- Status last verified
- Jun 2015
- First submitted
- 5 Jun 2013
- Last updated
- 25 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01877122
- Acronym / sponsor ID
- MS1-1004
- Conditions
- Hernia, Inguinal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Samyang Biopharmaceuticals CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 Jun 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.
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proflex® Mesh | Experimental | Device: Proflex® Mesh Mesh implantationDevice: Partially absorbable lightweight mesh Intervention: Mesh implantation |
| Marlex® Mesh | Active comparator | Device: Marlex® Mesh ImplantDevice: Non-absorbable Heavyweight mesh Intervention: Mesh implantation |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients >=20 years =<85 years old
- Patients with Unilateral hernia
- Patients without previous operations in lower part of abdomen
- Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
- Patients capable to participate during the period of the trial
Key exclusion criteria (15 listed)
- Previous hernia repair at the same site
- Incarcerated hernia
- Strangulated hernia
- Patients to whom and open surgery cannot be indicated
- Previous urological surgery
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 |
|---|---|---|
| Proflex® Mesh Mesh implantationImplantation of mesh in the incision of inguinal area | Device | Proflex® Mesh |
| Marlex® Mesh Implant | Device | Marlex® Mesh |
Primary outcome
pain score (10-point Visual Analogue Scale)
Time frame: Day90 after operation
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 25 Jun 2015.
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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.
Taeil Son, M.D., Ph.D. principal investigator
Eulji Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Proflex® Mesh Mesh implantation and Marlex® Mesh Implant in people with Hernia, Inguinal, run by Samyang Biopharmaceuticals Corporation at 1 site in South Korea.
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 5 inclusion and 15 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 25 Jun 2015. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
pain score (10-point Visual Analogue Scale) (time frame: Day90 after operation). 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 25 Jun 2015.