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

NCT06912945 | Enrolling By Invitation

• 1 other identifier: Soh-Med-24-12-3MD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Laryngeal Lesion

Keywords

diode; benign; laryngeal; laser

Outcome Measures

Primary Outcomes (2)

• change in voice handicap index Arabic version (VHI-Arabic)

  change in Voice handicap index Arabic version from baseline before treatment and after treatment

  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

  2 months after treatment

Study Arms (3)

Group (A)

ACTIVE COMPARATOR

using diode laser 980nm wavelength in benign laryngeal lesions

Procedure: using diode laser 980nm wavelength in benign laryngeal lesions

Group (B)

ACTIVE COMPARATOR

using diode laser 450nm wavelength in benign laryngeal lesions

Procedure: using diode laser 450nm wavelength in benign laryngeal lesions

Group (C)

ACTIVE COMPARATOR

using traditional cold instrumentations in benign laryngeal lesions

Procedure: using traditional cold instrumentations in benign laryngeal lesions

Interventions

using diode laser 980nm wavelength in benign laryngeal lesions PROCEDURE

using diode laser 980nm wavelength in treatment of benign laryngeal lesions

Group (A)

using diode laser 450nm wavelength in benign laryngeal lesions PROCEDURE

using diode laser 450nm wavelength in treatment of benign laryngeal lesions

Group (B)

using traditional cold instrumentations in benign laryngeal lesions PROCEDURE

using traditional cold instrumentations in treatment of benign laryngeal lesions

Group (C)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients with benign laryngeal lesions

You may not qualify if:

• patients presenting with or have history of malignant laryngeal lesion

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University

Sohag, Sohag Governorate, 82511, Egypt

Location

Related Publications (1)

• 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.

  PMID: 27096024 BACKGROUND

MeSH Terms

Conditions

Laryngeal Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Mohammed Abdu Elsamea, Assistant lecturer

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Otorhinolaryngology

Study Record Dates

• First Submitted: March 25, 2025
• First Posted: April 6, 2025
• Study Start: October 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

EG (1)