New Method to Close Nasal Septal Perforation | NCT06439927

Studies
New Method to Close Nasal Septal Perforation

NCT06439927

Sponsor

Helwan University

Status

Recruiting

Last Update Posted

Nov 5, 2024Actual

Enrollment

23Estimated

Phase

Not Applicable

Conditions

Nasal Perforated Septum

Interventions

Polycaprolactone nasal mesh

Countries

Egypt

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

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 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

May 28, 2024

First Submission Date that Met QC Criteria

May 28, 2024

First Posted Date

Jun 3, 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 3, 2024

Last Update Posted Date

Nov 5, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Hossam Sebaey, Assistant lecturer of otorhinolaryngology, Helwan UniversityPrincipal Investigator

Lead Sponsor

Helwan UniversityOTHER

Collaborators

Not provided

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

The goal of this clinical trial is to investigate if a 3-dimensional fabricated nasal mesh works to close nasal septal perforations. Under general anesthesia, during nasal septal perforation repair surgery, the investigator will place the mesh between the elevated mucoperichondrial flaps opposite the site of the perforation and confirm its original position at both sides under nasal endoscope. Endoscopic examination for septal mucosa status will be done monthly for a three months follow up period.

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

23Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Polycaprolactone nasal mesh	Experimental		Device: Polycaprolactone nasal mesh

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Polycaprolactone nasal mesh	Device	a 3-dimensional fabricated Polycaprolactone nasal mesh	Polycaprolactone nasal mesh

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean Change in Post-operative healing of septal perforation	Endoscopic evaluation of nasal septal mucosa status will be classified as complete bilateral healing, complete unilateral healing, no healing, and perforation.	for a three months follow up period

Secondary Outcomes

Measure	Description	Time Frame
Postoperative complications	The following complications will be evaluated on a present/absent basis:hematoma-infection-allergy	for a three months follow up period

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing nasal septal perforation repair surgery.

Exclusion Criteria:

Patients with known allergy to polycaprolactone.
Pregnancy or lactation.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

58 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed H Sebaey, Master degree	Contact	01008306356		mohamed.h757@hotmail.com

Overall Officials

Name	Affiliation	Role
Mohamed H Sebaey, master degree	Helwan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine, Helwan University	Recruiting	Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D061270	Nasal Septal Perforation

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided