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Efficacy and safety of the self-retainer in endoscopic ear surgery

Efficacy and safety of the self-retainer in endoscopic ear surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007276
Enrollment
50
Registered
2022-05-13
Start date
2022-06-29
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

None listed

Interventions

Medical Device, Procedure/Surgery : Subjects participating in the study are assigned 1:1 to the group using the self-retainer (experimental group) and the conventional treatment group (control group).

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Chronic otitis media under endoscopic tympanoplasty with 1. Adult patients aged 19 and over 2. Patients who can understand the surgical treatment of chronic otitis media 3. Patients who can participate in follow-up for more than one month after surgery 4. Patient who agrees to participate in the clinical study and have signed a written consent form him/herself

Exclusion criteria

Exclusion criteria: 1. Those who cannot consent voluntarily (this study does not require consent from agents) 2. Patients with difficulty in undergoing surgery

Design outcomes

Primary

MeasureTime frame
Subjective satisfaction of the operator, evaluation of surgical field of view, ease of use of instruments, evaluation of retainer (insertion, removal, location), evaluation of damage to the external ear canal

Secondary

MeasureTime frame
degree of bleeding during surgery, frequency of endoscopic cleaning during surgery, total time for endoscopic surgery;Postoperative pain level, allergic reaction, discoloration or abnormal sensation of the external auditory canal

Countries

Korea, Republic of

Contacts

Public ContactJong Woo Chung

Asan Medical Center

jwchung@amc.seoul.kr+82-2-3010-3718

Outcome results

None listed

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