Viewing Study NCT05423067


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Study NCT ID: NCT05423067
Status: COMPLETED
Last Update Posted: 2022-06-21
First Post: 2015-12-09
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding
Sponsor: Mansoura Integrated Fertility Center
Organization:

Study Overview

Official Title: Interventional Gynecologic Surgery
Status: COMPLETED
Status Verified Date: 2022-06
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: Prospective observational interventional study , The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Detailed Description: Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.

Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.

Patients and Methods: The study done in two phases:

1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.

Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.

Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: