Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868812
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2020-11-27
Brief Title:
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated Carbon Dioxide CO2 Laser Treatment
Sponsor:
IRCCS San Raffaele
Organization:
IRCCS San Raffaele
Study Overview
Official Title:
Histological Modifications of Postmenopausal Vaginal Mucosa After Repeated CO2 Laser
Status:
COMPLETED
Status Verified Date:
2022-09
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:
REPLAMOD
Brief Summary:
To assess the long-term histological and clinical efficacy of MonaLisa Touch procedure for the management of the Genitourinary Syndrome of Menopause GSM in postmenopausal female patients
Detailed Description:
The investigator propose a prospective case series of 15 postmenopausal women with bothersome symptoms of GSM treated with MonaLisa Touch CO2 laser The investigator hypothesize that even in the long term MonaLisa Touch will significantly improve GSM histologically and clinically from baseline
The primary outcome objective of the study is to evaluate the histological modifications of the vaginal mucosa after repeated CO2 Monalisa Touch laser treatment The investigator shall evaluate the role of this treatment by calculating the difference in vaginal epithelial thickness between the biopsy obtained before the start of laser treatment and the biopsy obtained after treatment In addition the study will analyze the safety of repeated laser treatments verifying the absence of fibrosis formation in the vaginal mucosa Secondary objectives of the study will include an evaluation of the clinical effects associated with repeated Monalisa Touch CO2 laser treatments using validated questionnaires
All participants will be screened to ensure inclusionexclusion criteria are met A biopsy will be taken from each patient one month before the first laser treatment and one month after the last laser treatment The MonaLisa treatment will be performed monthly for 3 months MonaLisa treatment with fractional microablative laser system For subjects with concomitant vulvar symptoms vulvar treatment will be done Biopsy samples will be analyzed with Hematoxylin- Eosin and Trichrome staining Periodic acid-Schiff PAS reaction for glycogen and immunohistochemistry for CD34 a vessel marker All clinical questionnaires will be assessed at baseline and at one month after the last session
The primary outcome objective of the study is to evaluate the histological modifications of the vaginal mucosa after repeated CO2 Monalisa Touch laser treatment The investigator shall evaluate the role of this treatment by calculating the difference in vaginal epithelial thickness between the biopsy obtained before the start of laser treatment and the biopsy obtained after treatment In addition the study will analyze the safety of repeated laser treatments verifying the absence of fibrosis formation in the vaginal mucosa Secondary objectives of the study will include an evaluation of the clinical effects associated with repeated Monalisa Touch CO2 laser treatments using validated questionnaires
All participants will be screened to ensure inclusionexclusion criteria are met A biopsy will be taken from each patient one month before the first laser treatment and one month after the last laser treatment The MonaLisa treatment will be performed monthly for 3 months MonaLisa treatment with fractional microablative laser system For subjects with concomitant vulvar symptoms vulvar treatment will be done Biopsy samples will be analyzed with Hematoxylin- Eosin and Trichrome staining Periodic acid-Schiff PAS reaction for glycogen and immunohistochemistry for CD34 a vessel marker All clinical questionnaires will be assessed at baseline and at one month after the last session
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?:
False
Is an FDA AA801 Violation?:
None