Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05702281
Status:
RECRUITING
Last Update Posted:
2023-12-08
First Post:
2021-06-22
Brief Title:
Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Evaluation of the Safety and Efficacy of the ReLARC Inserter During the Insertion Procedure of GYNEFIX Intrauterine Copper Bearing Contraceptive Device With a Follow-up of 3 Years
Status:
RECRUITING
Status Verified Date:
2023-12
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:
ReLARC
Brief Summary:
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion to assess uterine compatibility and the assurance of proper device placement ReLARC is a GyneFix device intended to be inserted via hysteroscopy Hysteroscopic insertion of the device allows direct visualization of the procedure which makes it extremely safe
This multicentre open-label study will take place in the Womens Clinic of the Ghent University Hospital in Belgium International Coordinating Centre and in the University Hospital AOU Federico II of Naples in Italy
Primary aim
To evaluate the safety of the ReLARC inserter during the insertion procedure of GyneFix intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations
Providing no complications develop participants will remain in the study for 3 years 120 women will be enrolled
This multicentre open-label study will take place in the Womens Clinic of the Ghent University Hospital in Belgium International Coordinating Centre and in the University Hospital AOU Federico II of Naples in Italy
Primary aim
To evaluate the safety of the ReLARC inserter during the insertion procedure of GyneFix intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations
Providing no complications develop participants will remain in the study for 3 years 120 women will be enrolled
Detailed Description:
Insertion under vision such as hysteroscopy allows the ability to visualize the uterus prior to insertion to assess uterine compatibility and the assurance of proper device placement ReLARC is a GyneFix device intended to be inserted via hysteroscopy Hysteroscopic insertion of the device allows direct visualization of the procedure which makes it extremely safe
This multicentre open-label study will take place in the Womens Clinic of the Ghent University Hospital in Belgium International Coordinating Centre and in the University Hospital AOU Federico II of Naples in Italy
Primary aim
To evaluate the safety of the ReLARC inserter during the insertion procedure of GyneFix intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations
Providing no complications develop participants will remain in the study for 3 years 120 women will be enrolled During the screeningsvisit the physician will introduce the trial During the enrolment visit the patient will sign the informed consent if she agrees to participate During the insertion visit the IUD will be placed the correct location of the device will be determined the ease of ReLARC insertion and hysteroscope insertion will be measured the learning curve of the insertion will be registered and the pain score of the patient will be registered
After 4-8 weeks the first follow-up visit will take place The location of the device will be determined and a satisfactory score of the patient about the IUD During 3 years theres a yearly consultation with the gynaecologist where the location of the device and the satisfactory score about the IUD will be determined
This multicentre open-label study will take place in the Womens Clinic of the Ghent University Hospital in Belgium International Coordinating Centre and in the University Hospital AOU Federico II of Naples in Italy
Primary aim
To evaluate the safety of the ReLARC inserter during the insertion procedure of GyneFix intrauterine copper bearing contraceptive devices by means of successful placement with adequate position during follow-up evaluations
Providing no complications develop participants will remain in the study for 3 years 120 women will be enrolled During the screeningsvisit the physician will introduce the trial During the enrolment visit the patient will sign the informed consent if she agrees to participate During the insertion visit the IUD will be placed the correct location of the device will be determined the ease of ReLARC insertion and hysteroscope insertion will be measured the learning curve of the insertion will be registered and the pain score of the patient will be registered
After 4-8 weeks the first follow-up visit will take place The location of the device will be determined and a satisfactory score of the patient about the IUD During 3 years theres a yearly consultation with the gynaecologist where the location of the device and the satisfactory score about the IUD will be determined
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