NCT03807713

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Oticon Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2018-09-07
• Primary completion: 2019-11-06
• Completion: 2022-03-29
• First posted: 2019-01-17
• Last updated: 2022-04-20

Locations

1 site across 1 country: Netherlands