Inguinal HerniaNCT04171102
Neo-nervegenesis in Inguinal Hernia Implant ProFlor
A study testing ProFlor Hernia implant in people with Inguinal Hernia, run by University of Cagliari.
Trial summary
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- ProFlor Hernia implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
- Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
- Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor
Who cannot join
- Patients who underwent inguinal hernia repair with conventional flat meshes
About this study
Official title: Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
Read the detailed description
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.
- Conditions
- Inguinal Hernia
- Being tested
- ProFlor Hernia implant
- Keywords
- Hernia implants, Biologic response, Neo-nervegenesis, Regenerative scaffold
- 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 implantDevice
Inguinal hernia repair
| Study group | Role | What they receive |
|---|---|---|
| Short term post inguinal hernia repair wit ProFlor | Active comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation Receives: Device: ProFlor Hernia implant |
| Mid term post inguinal hernia repair wit ProFlor | Active comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation Receives: Device: ProFlor Hernia implant |
| Long term post inguinal hernia repair wit ProFlor | Active comparator | Determining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation Receives: Device: ProFlor Hernia implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor
Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation
Measured: 3 weeks until 8 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study startJan 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Amato, University of Cagliari
- Investigators
- Giuseppe Amato, MD, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171102
- Sponsor's protocol ID
- Neo-nervegenesis in ProFlor
- Status last verified
- Jun 2020
- First submitted
- 15 Nov 2019
- Last updated
- 17 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Tissue specimen and histological records upon request
Publications
Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
PubMed 21752035Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
PubMed 25626584Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.
PubMed 30318605Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.
PubMed 32169570
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neo-neurogenesis in 3D Dynamic Responsive Implant for Inguinal Hernia Repair PorFlor
- ClinicalTrials.gov ID
- NCT04171102
- Acronym / sponsor ID
- Neo-nervegenesis in ProFlor
- Conditions
- Inguinal Hernia
- Keywords
- Hernia implants, Biologic response, Neo-nervegenesis, Regenerative scaffold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Nov 2019 (actual)
- Results
- Posted 11 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.
Detailed description
Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short term post inguinal hernia repair wit ProFlor | Active comparator | Device: ProFlor Hernia implantDetermining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-5 weeks post implantation |
| Mid term post inguinal hernia repair wit ProFlor | Active comparator | Device: ProFlor Hernia implantDetermining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 3-4 months post implantation |
| Long term post inguinal hernia repair wit ProFlor | Active comparator | Device: ProFlor Hernia implantDetermining presence and level of maturation of nervous structures in the hernia implant named ProFlor at 6-8 months post implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
- Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
- Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor
Key exclusion criteria (1 listed)
- Patients who underwent inguinal hernia repair with conventional flat meshes
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 implantInguinal hernia repair | Device | Long term post inguinal hernia repair wit ProFlor, Mid term post inguinal hernia repair wit ProFlor, Short term post inguinal hernia repair wit ProFlor |
Primary outcome
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor
Time frame: 3 weeks until 8 months post-implantation
Post-operative assessment of neonervegenesis within hernia implant ProFlor at short, mid and long term post-implantation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21752035Amato G, Lo Monte AI, Cassata G, Damiano G, Romano G, Bussani R. A new prosthetic implant for inguinal hernia repair: its features in a porcine experimental model. Artif Organs. 2011 Aug;35(8):E181-90. doi: 10.1111/j.1525-1594.2011.01272.x. Epub 2011 Jul 13.
- Background: PubMed 25626584Amato G, Romano G, Agrusa A, Marasa S, Cocorullo G, Gulotta G, Goetze T, Puleio R. Biologic response of inguinal hernia prosthetics: a comparative study of conventional static meshes versus 3D dynamic implants. Artif Organs. 2015 Jan;39(1):E10-23. doi: 10.1111/aor.12416.
- Background: PubMed 30318605Amato G, Romano G, Puleio R, Agrusa A, Goetze T, Gulotta E, Gordini L, Erdas E, Calo P. Neomyogenesis in 3D Dynamic Responsive Prosthesis for Inguinal Hernia Repair. Artif Organs. 2018 Dec;42(12):1216-1223. doi: 10.1111/aor.13286. Epub 2018 Oct 14.
- Results publication: PubMed 32169570Amato G, Agrusa A, Puleio R, Calo P, Goetze T, Romano G. Neo-nervegenesis in 3D dynamic responsive implant for inguinal hernia repair. Qualitative study. Int J Surg. 2020 Apr;76:114-119. doi: 10.1016/j.ijsu.2020.02.046. Epub 2020 Mar 10.
- Individual participant dataSharing planned: Yes. Tissue specimen and histological records upon request
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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.
Giuseppe Amato, MD principal investigator
University of Cagliari
Questions about this trial
What is this clinical trial studying?
A study testing ProFlor Hernia implant in people with Inguinal Hernia, run by University of Cagliari.
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 1 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 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 11 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ingrowth of Newly Formed Nervous Elements Within Hernia Implant ProFlor (time frame: 3 weeks until 8 months post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171102, which also lists 4 linked publications.
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 17 Jun 2020.