Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363903
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-02-26
Brief Title:
ASIA-Mesh a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation
Sponsor:
Maxima Medical Center
Organization:
Maxima Medical Center
Study Overview
Official Title:
AutoimmumeInflammatory Syndrome Induced by Adjuvants ASIA Syndrome Caused by Polypropylene Mesh Implantation - a Pilot Study for Diagnostics and Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In the present pilot study a possible relation between the implantation of PP mesh for inguinal hernia vaginal prolapse and SUI repair and subsequent systemic auto-immune complaints is investigated by testing immunologic and allergic responses in fifty patients with suspected ASIA syndrome Additional value of MAT is investigated and effectiveness of partial PP mesh removal for these complaints is assessed If so a profound insight in diagnostics and treatment for systematic complaints will be attained that may provide opportunities for future diagnostics
Detailed Description:
Worldwide there is a lot of commotion about the effects and complications of various implants In analogy to patients with silicone breast implants some patients report various systemic complaints following inguinal polypropylene PP mesh implantation suggesting AutoinflammatoryAutoimmunity Syndrome Induced by Adjuvants ASIA Shoenfelds syndrome or some other suspected systemic auto-immuneinflammatory response Although an evidence-based and causal relationship is lacking patients report serious complaints Therefore the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup including an elaborate anamnesis conventional immunologic analyses and mesh allergy testing MAT Further in case the implant is removed as part of the treatment due to a persistent wish of the patient the PP explant will be histologically examined to find additional cues for an auto-immuneinflammatory response and thus ASIA So far evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None