Benign Laryngeal LesionLASERNCT06912945
Factors Affecting Outcomes of Using Diode Laser Both 980 nm Wave Length and 450 Wavelength on Benign Laryngeal Lesions in Comparison to Traditional Cold Instrumentations as Regard Parameters of Laser Device, Nature of Lesion and Patient Factors
A study testing using diode laser 980nm wavelength in benign laryngeal lesions, using diode laser 450nm wavelength in benign laryngeal lesions and using traditional cold instrumentations in benign laryngeal lesions in people with Benign Laryngeal Lesion, run by Sohag University at 1 site in Egypt.
Trial summary
Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Laryngeal Lesion
- What is being tested?
- using diode laser 980nm wavelength in benign laryngeal lesions, using diode laser 450nm wavelength in benign laryngeal lesions and using traditional cold instrumentations in benign laryngeal lesions
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with benign laryngeal lesions
Who cannot join
- patients presenting with or have history of malignant laryngeal lesion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Factors Affecting the Outcomes of Using the Diode Laser in Benign Laryngeal Lesions
Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations
- Conditions
- Benign Laryngeal Lesion
- Being tested
- using diode laser 980nm wavelength in benign laryngeal lesions, using diode laser 450nm wavelength in benign laryngeal lesions, using traditional cold instrumentations in benign laryngeal lesions
- Keywords
- diode, benign, laryngeal, laser
- Medical subject headings
- Laryngeal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using diode laser 980nm wavelength in benign laryngeal lesionsProcedure or surgery
using diode laser 980nm wavelength in treatment of benign laryngeal lesions
using diode laser 450nm wavelength in benign laryngeal lesionsProcedure or surgery
using diode laser 450nm wavelength in treatment of benign laryngeal lesions
using traditional cold instrumentations in benign laryngeal lesionsProcedure or surgery
using traditional cold instrumentations in treatment of benign laryngeal lesions
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Active comparator | using diode laser 980nm wavelength in benign laryngeal lesions Receives: Procedure: using diode laser 980nm wavelength in benign laryngeal lesions |
| Group (B) | Active comparator | using diode laser 450nm wavelength in benign laryngeal lesions Receives: Procedure: using diode laser 450nm wavelength in benign laryngeal lesions |
| Group (C) | Active comparator | using traditional cold instrumentations in benign laryngeal lesions Receives: Procedure: using traditional cold instrumentations in benign laryngeal lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in voice handicap index Arabic version (VHI-Arabic)
change in Voice handicap index Arabic version from baseline before treatment and after treatment
Measured: 2 months after treatment
change in voice acoustic analysis
change in voice acoustic analysis including change in jitter and shimmer values from baseline preoperative and 2 months after treatment
Measured: 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start1 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
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 Benign Laryngeal LesionStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abdu Elsamea Elsaman, Sohag University
- Investigators
- Mohammed Abdu Elsamea, Assistant lecturer, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912945
- Sponsor's protocol ID
- Soh-Med-24-12-3MD
- Acronym
- LASER
- Status last verified
- Aug 2025
- First submitted
- 25 Mar 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arroyo HH, Neri L, Fussuma CY, Imamura R. Diode Laser for Laryngeal Surgery: a Systematic Review. Int Arch Otorhinolaryngol. 2016 Apr;20(2):172-9. doi: 10.1055/s-0036-1579741. Epub 2016 Mar 4.
PubMed 27096024
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting the Outcomes of Using the Diode Laser in Benign Laryngeal Lesions
- ClinicalTrials.gov ID
- NCT06912945
- Acronym / sponsor ID
- LASER / Soh-Med-24-12-3MD
- Conditions
- Benign Laryngeal Lesion
- Keywords
- diode, benign, laryngeal, laser
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
Studying the different Factors affecting the outcomes of using diode laser both 980 nm wave length and 450 wavelength on benign laryngeal lesions in comparison to traditional cold instrumentations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Active comparator | Procedure: using diode laser 980nm wavelength in benign laryngeal lesionsusing diode laser 980nm wavelength in benign laryngeal lesions |
| Group (B) | Active comparator | Procedure: using diode laser 450nm wavelength in benign laryngeal lesionsusing diode laser 450nm wavelength in benign laryngeal lesions |
| Group (C) | Active comparator | Procedure: using traditional cold instrumentations in benign laryngeal lesionsusing traditional cold instrumentations in benign laryngeal lesions |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with benign laryngeal lesions
Key exclusion criteria (1 listed)
- patients presenting with or have history of malignant laryngeal lesion
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 |
|---|---|---|
| using diode laser 980nm wavelength in benign laryngeal lesionsusing diode laser 980nm wavelength in treatment of benign laryngeal lesions | Procedure or surgery | Group (A) |
| using diode laser 450nm wavelength in benign laryngeal lesionsusing diode laser 450nm wavelength in treatment of benign laryngeal lesions | Procedure or surgery | Group (B) |
| using traditional cold instrumentations in benign laryngeal lesionsusing traditional cold instrumentations in treatment of benign laryngeal lesions | Procedure or surgery | Group (C) |
Primary outcome
change in voice handicap index Arabic version (VHI-Arabic)
Time frame: 2 months after treatment
change in Voice handicap index Arabic version from baseline before treatment and after treatment
change in voice acoustic analysis
Time frame: 2 months after treatment
change in voice acoustic analysis including change in jitter and shimmer values from baseline preoperative and 2 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 27096024Arroyo HH, Neri L, Fussuma CY, Imamura R. Diode Laser for Laryngeal Surgery: a Systematic Review. Int Arch Otorhinolaryngol. 2016 Apr;20(2):172-9. doi: 10.1055/s-0036-1579741. Epub 2016 Mar 4.
- Individual participant dataSharing planned: Undecided
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.
Mohammed Abdu Elsamea, Assistant lecturer principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using diode laser 980nm wavelength in benign laryngeal lesions, using diode laser 450nm wavelength in benign laryngeal lesions and using traditional cold instrumentations in benign laryngeal lesions in people with Benign Laryngeal Lesion, run by Sohag 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: enrolling by invitation, as of the sponsor's last update on 24 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
change in voice handicap index Arabic version (VHI-Arabic) (time frame: 2 months after treatment). The study lists 2 primary outcomes in all. 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 NCT06912945, 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 24 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.