Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355713
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-28
Brief Title:
Improvement of Symptoms After Removal of the Essure Contraceptive Implant
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Prospective Multicenter Study of the Improvement of Symptoms After Removal of the Essure Contraceptive Implant
Status:
NOT_YET_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:
ABLES
Brief Summary:
ESSURE is an implantable medical device for definitive and irreversible sterilization indicated for adult women of childbearing age These implants are inserted into the fallopian tubes by hysteroscopy Marketed in 2002 ESSURE contraceptive implants were withdrawn from the French market in 2017 and worldwide in 2017 and 2018 following the observation in certain patients of polymorphic and non-specific gynecological and extra-gynecological symptoms Studies with small numbers and short-term follow-up have shown a significant improvement in these symptoms after implant explantation This constitutes a real public health problem since according to the report of the EPI-PHARE Scientific Interest Group 198000 French women have these implants and only 30000 of them or 15 have been explanted knowing that explantation of ESSURE implants is recommended only in symptomatic patients A large number of these patients presenting symptoms have not yet been treated for an explant
The physiopathological mechanisms is are not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory andor allergic andor autoimmune phenomena
Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients determine the most appropriate surgical techniques and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers From a surgical point of view there is a real risk of fracture of implants whatever the type of intervention performed study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation From a biological point of view the dosage of the metallic elements constituting ESSURE implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body Analysis of pro-inflammatory cytokines micro-RNAs miRNA quantitative analysis of inflammatory pathway messenger ribonucleic acid mRNAs NanoString technology and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms This study responds to a significant request from patient associations
The physiopathological mechanisms is are not yet determined but several arguments are in favor of a dissemination of metallic elements contained in these implants whose accumulation could lead to inflammatory andor allergic andor autoimmune phenomena
Carrying out a prospective study with long-term longitudinal follow-up appears essential to precisely assess the degree of improvement in the symptoms and quality of life of these patients determine the most appropriate surgical techniques and understand the pathophysiological mechanisms that may result in the implementation of specific treatments and relevant markers From a surgical point of view there is a real risk of fracture of implants whatever the type of intervention performed study the biomechanical properties of implants with a view to characterizing their behavior to mechanical rupture but also their thermal resistance in an objective manner seems essential to limit the risk of fracture and help to inform the patient about the surgical technique proposed for explantation From a biological point of view the dosage of the metallic elements constituting ESSURE implants and potentially toxic ones could make it possible to objectify the release of these metallic elements in the body Analysis of pro-inflammatory cytokines micro-RNAs miRNA quantitative analysis of inflammatory pathway messenger ribonucleic acid mRNAs NanoString technology and analysis of neuroinflammation by functional imaging should make it possible to explore potential pathophysiological mechanisms This study responds to a significant request from patient associations
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02010-45 | OTHER | ID-RCB | None |