NCT03281967

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2018

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

August 31, 2017

Last Update Submit

March 2, 2021

Conditions

Bone Conduction DeafnessUnilateral DeafnessMiddle Ear DeafnessMixed Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Numbness (sensibility) around surgery area

    The primary objective of the study is to investigate the difference in numbness around implant after MIPS procedure (test, this investigation) and a surgery with soft tissue preservation (control, from a previous study, C47) for implanting Oticon Medical implants and abutments. Two different sensibilities will be tested by means of a broken wooden cotton swab/bud (q-tip): gnostic (with cotton side) and vital (with broken, sharp wooden side) sensibility. The measurement locations will be standardized at specific positions from surgery location, and the same location (with respect to the surgery site) will be used for sensibility measurement for each patient visit. Both the area (diameter in cm) and the degree (scale form 0 (no complaints) to 10 (maximum complaints)) will be monitored. Additionally, patients' subjective sensibility judgment around surgery area on a scale of 0-10 will be recorded.

    6 months post surgery

Secondary Outcomes (9)

  • Time needed for surgery

    At surgery

  • Unplanned visit

    36 months

  • Adverse Events

    36 months

  • Pain perception by patient

    36 months

  • Implant survivability

    36 months

  • +4 more secondary outcomes

Study Arms (1)

Minimally Invasive Ponto Surgery

OTHER

Surgical method for installation of a bone anchored hearing system for hearing rehabilitation

Device: Minimally Invasive Ponto Surgery

Interventions

Minimally Invasive Ponto SurgeryDEVICE

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

Minimally Invasive Ponto Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University Medical Center St Radboud

Nijmegen, 6500, Netherlands

Location

MeSH Terms

Conditions

Hearing Loss, UnilateralHearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Myrthe Hol, MD, PhD

    Radboud UMC, Department of Otorhinolaryngology. The Netherlands

    PRINCIPAL INVESTIGATOR

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

August 31, 2017

First Posted

September 13, 2017

Study Start

June 9, 2017

Primary Completion

June 13, 2018

Study Completion

December 21, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)