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Diode laser assisted stapes implantation and conventional endoscopic stapes implantation for the treatment of otosclerosis: a double-blind randomized clinical trial

Diode laser assisted stapes implantation and conventional endoscopic stapes implantation for the treatment of otosclerosis: a double-blind randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080427
Enrollment
Unknown
Registered
2024-01-29
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Interventions

Diode laser group:A 980 nm diode laser (DEKA SmartXide2 laser system
C60 p/n: M103F1
DEKA Optical Technology Co., Ltd., Beijing, China) was used to complete fenestration of the stapes footplate and/or laser cutting of the posterior and/or anterior arch. The emission mode was CW, sing
Conventional endoscopic surgery group:Use a triangular needle or micro-drill to complete the stapes footplate fenestration (non-laser), and use a foot arch scissors or hook needle to break the stapes

Sponsors

Eye & ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients between the ages of 18 and 70 who are willing to undergo stapes implantation surgery with otosclerosis

Exclusion criteria

Exclusion criteria: (1) Patients with active otosclerosis lesions and revision cases; (2) CHL caused by trauma, serous otitis media, congenital ear malformations, and other reasons; (3) Middle ear infection and/or perforation of the eardrum; (4) Mixed hearing loss or SNHL; Or (5) uncontrolled diabetes and hypertension.

Design outcomes

Primary

MeasureTime frame
Hearing level;Hearing gain rate;

Secondary

MeasureTime frame
Otoendoscope;CT scan ;Incidence of intraoperative complications;Postoperative complications;

Countries

China

Contacts

Public ContactRen Dongdong

Eye & ENT Hospital of Fudan University

dongdongren@fudan.edu.cn+86 138 0191 3332

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026