Erectile DysfunctionTSLANCT06743048
A Tissue Sparing, Laser Assisted Penile Prosthesis Implantation Technique
A study testing Tissue Sparing Laser Implantation in people with Erectile Dysfunction and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
Trial summary
A surgical technique using laser assisted penile prosthesis implantation Read more about this study
- Who is it for?
- Ages 21 to 81 years, men only
- Conditions the study is for
- Erectile Dysfunction, Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, Erectile Dysfunction Due to Arterial Disease
- What is being tested?
- Tissue Sparing Laser Implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 81 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men with ED not responding to medical treatment
Who cannot join
- Men with HBA1c more than 10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Sparing Laser Assisted Penile Prosthesis Implantation
A surgical technique using laser assisted penile prosthesis implantation
Read the 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
- 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
- Being tested
- Tissue Sparing Laser Implantation
- Keywords
- Cavernosal tissue sparing laser assisted implantation
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Sparing Laser ImplantationProcedure or surgery
A penile implant will be implanted using the cavernosal sparing technique and assisted by a laser fibre optic
| Study group | Role | What they receive |
|---|---|---|
| TSLA Group | Other | Tissue Sparing Laser Assisted Penile Implantation Receives: Procedure: Tissue Sparing Laser Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Penile prosthesis implantation
The penile implant is successfully implanted
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Jul 2022
- Primary completion1 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adham ZAAZAA, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743048
- Sponsor's protocol ID
- TSLA_Implantation
- Acronym
- TSLA
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sensitive data
Publications
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.
PubMed 30773500
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Sparing Laser Assisted Penile Prosthesis Implantation
- ClinicalTrials.gov ID
- NCT06743048
- Acronym / sponsor ID
- TSLA / TSLA_Implantation
- 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
- Keywords
- Cavernosal tissue sparing laser assisted implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 19 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TSLA Group | Other | Procedure: Tissue Sparing Laser ImplantationTissue Sparing Laser Assisted Penile Implantation |
Who may qualify
- Ages
- 21 to 81 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men with ED not responding to medical treatment
Key exclusion criteria (1 listed)
- Men with HBA1c more than 10
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tissue Sparing Laser ImplantationA penile implant will be implanted using the cavernosal sparing technique and assisted by a laser fibre optic | Procedure or surgery | TSLA Group |
Primary outcome
Successful Penile prosthesis implantation
Time frame: 1 hour
The penile implant is successfully implanted
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Background: PubMed 30773500Zaazaa 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.
- Individual participant dataSharing planned: No. Sensitive data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue Sparing Laser Implantation in people with Erectile Dysfunction and Erectile Dysfunction Associated With Type 2 Diabetes Mellitus, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Penile prosthesis implantation (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06743048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.