Evaluation of Clinical Outcomes of Ponto Procedures Performed in Settings Outside the Main Operating Room (i.e. Out-of-OR)

Part of paid clinical trials in Sacramento, California.

Sponsor
Oticon Medical
Study ID
NCT06930781
Status
Recruiting
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Conditions

  • Bone Anchored Hearing Aids
  • Hearing Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ponto implantation — DEVICE
    Ponto implantation is a surgical procedure to implant a bone-anchored hearing device, improving hearing by transmitting sound directly to the inner ear through bone conduction.

Study Details

This study is a combined retro- and prospective, single arm, multicentre investigation designed to follow clinical practice for Ponto-implantations performed out of OR. The overall objective is to investigate the complication rate for procedures performed out-of-OR.

Key Dates

First listed
Apr 16, 2025
Start date
May 7, 2025
Status verified
Jul 2026
Primary completion
Mar 30, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
270 participants (estimated)

Arms

  • Arm: Retrospective group
    Data gathered from retrospective chart reviews of patients who have undergone Ponto-implantation in an out-of-OR setting from 2019 and onwards
  • Arm: Prospective group
    Patients who have undergone Ponto implantation in an out-of-OR setting and participated in the study by filling out questionnaires.

Primary Outcome Measure

Intraoperative complications at surgery [ Time Frame: During the Ponto-implantation surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northern California Veterans Affairs Healthcare SystemSacramentoCalifornia95655
Dr Lane Squires
[email protected]
916-734-5400

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By research site
Northern California Veterans Affairs Healthcare System· Sacramento, CA

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