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Clinical Survey of Minimally Invasive Ponto Surgical Technique (MIPS)

NCT03281967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2021-03-03

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 Implant in patients indicated and counselled for Bone Anchored Hearing System.

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
2017-06-09
Primary Completion
2018-06-13
Completion
2020-12-21

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 NCT03281967 on ClinicalTrials.gov