Clinical Study of Minimally Invasive Ponto Surgical Technique (MIPS) - Design Iteration
1 other identifier
interventional
25
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2018
CompletedFirst Submitted
Initial submission to the registry
January 8, 2019
CompletedFirst Posted
Study publicly available on registry
January 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 29, 2022
CompletedApril 20, 2022
March 1, 2021
1.2 years
January 8, 2019
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Numbness (sensibility) around the implant
Total numbness around the implant will be assessed as a combination of gnostic and vital sensibility.
6 months post surgery
Secondary Outcomes (14)
Length of surgery
At surgery
Unplanned visits
36 months
Adverse skin reactions
36 months
Adverse skin reactions
36 months
Pain perception by patient
36 months
- +9 more secondary outcomes
Study Arms (1)
Minimally Invasive Ponto Surgery
OTHERSurgical method for installation of a bone anchored hearing system for hearing rehabilitation
Interventions
Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
Eligibility Criteria
You may qualify if:
- years or older.
- Patient indicated for an ear level bone anchored sound processor.
- Healthy bone quality to allow for 4mm implant insertion.
You may not qualify if:
- Intraoperative switch to an alternative surgical technique
- Patients undergoing re-implantation (on the side being included in the study)
- Previous participation in the C47 study.
- Inability to participate in follow-up.
- Psychiatric disease in the medical history.
- Mental disability.
- Presumed doubt, for any reason, that the patient will be able to show up on all follow-ups.
- Diseases or treatments known to compromise the bone quality at the implant site, e.g. radiotherapy, osteoporosis, diabetes mellitus.
- Patients with natural skin height of \>12mm (as there will be additional skin reduction needed)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oticon Medicallead
Study Sites (1)
Radboud University Medical Center
Nijmegen, 6525, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myrthe Hol, MD, PhD
Radboud UMC, Department of Otorhinolaryngology. The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2019
First Posted
January 17, 2019
Study Start
September 7, 2018
Primary Completion
November 6, 2019
Study Completion
March 29, 2022
Last Updated
April 20, 2022
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share