Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-01-01
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Short term post inguinal hernia repair with ProFlor
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 1 to 3 months before to assess tissue incorporation into the 3D scaffold
ProFlor inguinal hernia device
Device follow up after inguinal hernia repair with ProFlor
Mid term post inguinal hernia repair with ProFlor
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor from 4 to 7 months before to assess tissue incorporation into the 3D scaffold
ProFlor inguinal hernia device
Device follow up after inguinal hernia repair with ProFlor
Long term post inguinal hernia repair with ProFlor
MRI of the pelvic area in patients who underwent inguinal hernia repair with ProFlor after 8 months and beyond to assess tissue incorporation into the 3D scaffold
ProFlor inguinal hernia device
Device follow up after inguinal hernia repair with ProFlor
Interventions
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ProFlor inguinal hernia device
Device follow up after inguinal hernia repair with ProFlor
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
Yes
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Giuseppe Amato
Consultant Professor
Principal Investigators
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Giuseppe Amato
Role: PRINCIPAL_INVESTIGATOR
University of Cagliari
Locations
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University of Palermo - Italy
Palermo, , Italy
Countries
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References
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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.
Amato 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.
Amato 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.
Amato 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.
Other Identifiers
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MR imaging of ProFlor
Identifier Type: -
Identifier Source: org_study_id
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