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Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration

NCT03807713 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-04-20

No results posted yet for this study

Summary

The objective of the study is to compare the outcomes after a surgical procedure with minimally invasive Ponto surgery (MIPS, test group) and tissue preservation surgery (control) for placing Oticon Medical Ponto implants and abutments.

Conditions

  • Bone Conduction Deafness
  • Unilateral Deafness
  • Middle Ear Deafness
  • Mixed Hearing Loss

Interventions

DEVICE

Minimally Invasive Ponto Surgery

Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.

Sponsors & Collaborators

  • Oticon Medical

    lead INDUSTRY

Principal Investigators

  • Myrthe Hol, MD, PhD · Radboud UMC, Department of Otorhinolaryngology. The Netherlands

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-07
Primary Completion
2019-11-06
Completion
2022-03-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03807713 on ClinicalTrials.gov