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Evaluation of the BHX Implant in Children With a BAHS

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ClinicalTrials.gov Identifier: NCT03742089
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Oticon Medical

Brief Summary:
The purpose of this study is to in a proactive manner collect high quality data from pediatric patients who have undergone a bone anchored hearing surgery, using the Ponto BHX implant, in clinical practice. This to further increase the knowledge of bone anchored hearing systems in the pediatric population.

Condition or disease Intervention/treatment
Hearing Loss, Conductive Device: Bone Anchored Hearing Surgery

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Implant Stability and Audiological Benefit of Oticon Medicals BHX Implant in Children Undergoing Surgery for a Percutaneous Bone Anchored Hearing System
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treatment
Bone Anchored Hearing Surgery using a BHX implant manufactured by Oticon Medical
Device: Bone Anchored Hearing Surgery
This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.




Primary Outcome Measures :
  1. Implant stability [ Time Frame: 6 months post surgery ]
    Implant stability will be assessed using resonance frequency analysis (RFA). This is a non-invasive technique using a SmartPeg (no 55) introduced into the abutment top. A probe is directed to the SmartPeg measuring the vibrations as a test for the stability of the interface between the fixture and the bone (osseointegration). The measurement renders Implant Stability Quotient (ISQ) 'numerical values from 1 to 100'; the higher the ISQ value, the higher the stability. Two perpendicular measurements will be performed at each site. The highest and lowest ISQ value obtained at each time point aree recorded. The Osstell ISQ instrument and SmartPegs from Osstell (Gothenburg, Sweden) will be used. Difference in mean of ISQ low at 6 months compared to surgery.



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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Pediatric population eligible for a bone anchored hearing surgery
Criteria

Inclusion Criteria:

  1. Patients who have decided to undergo a Bone Anchored Hearing Surgery and receive a Ponto system.
  2. Signed informed consent.
  3. Patients between 5 - 16 years of age.
  4. Patients eligible for one stage surgery.
  5. Patients who have been using Ponto sound processor on a soft band for at least 2 weeks.

Exclusion Criteria:

  1. Patients who cannot attend follow up visits.
  2. Patients with single side deafness (SSD).
  3. In surgeon's opinion, any other disorder and condition that may deem the patient unfit to participate in the study.
  4. Patients who receive other implant than the Ponto BHX.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742089


Contacts
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Contact: Arpita Singh, PhD +46 704541914 arsi@oticonmedical.com
Contact: Sofia Jonhede, MS +46763286731 sojo@oticonmedical.com

Locations
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United Kingdom
The James Cook University Hospital Recruiting
Middlesbrough, United Kingdom, TS4 3BE
Contact: Aniravan Banerjee, MS, FRCSed    +44 1642 854046    Anirvan.Banerjee@stees.nhs.uk   
Contact: Lisa Kennedy    +44 7853 138296    Lisa.Kennedy@stees.nhs.uk   
Principal Investigator: Aniravan Banerjee, MS, FRCEed         
Sponsors and Collaborators
Oticon Medical

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Responsible Party: Oticon Medical
ClinicalTrials.gov Identifier: NCT03742089     History of Changes
Other Study ID Numbers: C52
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms