- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06912945
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 (LASER)
August 18, 2025 updated by: Mohamed Abdelsamei Abdelgalil, Sohag University
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
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
108
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sohag, Egypt, 82511
- Sohag University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- All patients with benign laryngeal lesions
Exclusion Criteria:
- patients presenting with or have history of malignant laryngeal lesion
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group (A)
using diode laser 980nm wavelength in benign laryngeal lesions
|
using diode laser 980nm wavelength in treatment of benign laryngeal lesions
|
|
Active Comparator: Group (B)
using diode laser 450nm wavelength in benign laryngeal lesions
|
using diode laser 450nm wavelength in treatment of benign laryngeal lesions
|
|
Active Comparator: Group (C)
using traditional cold instrumentations in benign laryngeal lesions
|
using traditional cold instrumentations in treatment of benign laryngeal lesions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
2 months 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
|
2 months after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammed Abdu Elsamea, Assistant lecturer, Sohag University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2024
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
February 28, 2026
Study Registration Dates
First Submitted
March 25, 2025
First Submitted That Met QC Criteria
April 2, 2025
First Posted (Actual)
April 6, 2025
Study Record Updates
Last Update Posted (Actual)
August 24, 2025
Last Update Submitted That Met QC Criteria
August 18, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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