A Tissue Sparing, Laser Assisted Penile Prosthesis Implan... | NCT06743048

Studies
A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique

NCT06743048

Sponsor

Cairo University

Status

Completed

Last Update Posted

Dec 19, 2024Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Erectile Dysfunction
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Erectile Dysfunction Due to Arterial Disease
Erectile Dysfunction Due to Arterial Insufficiency
Erectile Dysfunction Due to Venous Disorder
Erectile Dysfunction Due to Neuropathy
Erectile Dysfunction Following Radical Prostatectomy

Interventions

Tissue Sparing Laser Implantation

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

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Nov 1, 2024Actual

Completion Date

Nov 30, 2024Actual

First Submitted Date

Dec 16, 2024

First Submission Date that Met QC Criteria

Dec 16, 2024

First Posted Date

Dec 19, 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

Dec 16, 2024

Last Update Posted Date

Dec 19, 2024Actual

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

A surgical technique using laser assisted penile prosthesis implantation

Detailed Description

A surgical technique using deep-red laser diode for visualization of the implantation track of the penile implant or Holium Laser for clearing the track whenever it is obstructed by fibrotic tissue.

Conditions Module

Conditions

Erectile Dysfunction
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
Erectile Dysfunction Due to Arterial Disease
Erectile Dysfunction Due to Arterial Insufficiency
Erectile Dysfunction Due to Venous Disorder
Erectile Dysfunction Due to Neuropathy
Erectile Dysfunction Following Radical Prostatectomy

Keywords

Cavernosal tissue sparing laser assisted implantation

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TSLA Group	Other	Tissue Sparing Laser Assisted Penile Implantation	Procedure: Tissue Sparing Laser Implantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tissue Sparing Laser Implantation	Procedure	A penile implant will be implanted using the cavernosal sparing technique and assisted by a laser fibre optic	TSLA Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful Penile prosthesis implantation	The penile implant is successfully implanted	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men with ED not responding to medical treatment

Exclusion Criteria:

Men with HBA1c more than 10

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Only Males requiring penile implants

Minimum Age

21 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30773500	Background	Zaazaa A, Mostafa T. Spontaneous Penile Tumescence by Sparing Cavernous Tissue in the Course of Malleable Penile Prosthesis Implantation. J Sex Med. 2019 Mar;16(3):474-478. doi: 10.1016/j.jsxm.2019.01.012. Epub 2019 Feb 14.

ID	Term
D005832	Genital Diseases, Male
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D012735	Sexual Dysfunction, Physiological
D052801	Male Urogenital Diseases
D020018	Sexual Dysfunctions, Psychological
D001523	Mental Disorders