Pectopexy Autologous Vs Mesh | NCT06524700

Studies
Pectopexy Autologous Vs Mesh

NCT06524700

Sponsor

Ain Shams Maternity Hospital

Status

Active, not recruiting

Last Update Posted

Nov 6, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Uterine Prolapse
Vault Prolapse, Vaginal

Interventions

pectopexy mesh
pectopexy autologous

Countries

Egypt
Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2024Actual

Primary Completion Date

Sep 1, 2025Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Jul 24, 2024

First Submission Date that Met QC Criteria

Jul 24, 2024

First Posted Date

Jul 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2024

Last Update Posted Date

Nov 6, 2024Actual

Name	Class
Armed forces hospital wadi aldwaser	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

prospective comparative study describing using autologous graft for uterine- vault - cervical suspension vs mesh in treatment of apical prolapse

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Procedure: pectopexy mesh
B	Active Comparator		Procedure: pectopexy autologous

Interventions

Name	Type	Description	Arm Group Labels	Other Names
pectopexy mesh	Procedure	pectopexy with mesh	A
pectopexy autologous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
POP-Q	assesment of degree of prolapse correction after surgery	3 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

uterine - vault prolapse

Exclusion Criteria:

previous vaginal repair for uterine or vaginal prolapse previous suspension procedures for apical prolapse

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamdy Saaid	UROGYNECOLOGY UNIT	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Urogynecology Unit		Cairo	Cairo Governorate		Egypt
Armed forces Hospital Wadi Aldwaser

Condition Browse Module

MeSH Terms

ID	Term
D014596	Uterine Prolapse
D056887	Pelvic Organ Prolapse
D011391	Prolapse

Ancestor Terms

ID	Term
D014591	Uterine Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided