NCT02092610

Brief Summary

An international multicentre, open, comparative, parallel group, prospective clinical investigation with a single 5 year follow up visit.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
3 countries

4 active sites

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

First Submitted

Initial submission to the registry

March 14, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 11, 2016

Completed
Last Updated

February 15, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

March 14, 2014

Results QC Date

October 26, 2015

Last Update Submit

January 12, 2016

Conditions

Conductive Hearing Loss

Outcome Measures

Primary Outcomes (1)

  • Implant Stability

    To show superiority of the novel implant compared to standard implants regarding stability of the implants measured as ISQ values at the abutment level. The ISQ value ranges from 1 to 100, the higher ISQ value, the higher the implant stabilty. Mean AUC 0-60 months ISQ represents a weighted average of the implant stability during the 60 months from start of the CAG5173 study to the measurement in this study CBAS5562. The ISQ 5 years value represents the single ISQ measurment at 5 years.

    At the single 60 months visit

Secondary Outcomes (3)

  • Longterm Survival of Implant

    At the single 60 months visit

  • Soft Tissue Status

    At the single 60 months visit

  • Implant Survival

    60 months

Study Arms (2)

Standard Implant BI300

ACTIVE COMPARATOR

The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Device: Standard Implant BI300

Novel Implant BI300

EXPERIMENTAL

The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Device: Novel Implant BI300

Interventions

Novel Implant BI300DEVICE

The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.

Novel Implant BI300
Standard Implant BI300DEVICE

The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long

Standard Implant BI300

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participated in the CAG5173 investigation
  • Signed informed consent

You may not qualify if:

  • Unable to follow investigational procedure
  • Any factor, at the discretion of the investigator, that is considered to contraindicate participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Radboud University Medical Center

Nijmegen, Netherlands

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

Salford Royal hospital

Salford, Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Myrthe Hol
Organization
Radboud University Hospital Nijmegen Medical Centre
Myrthe.Hol@radboudumc.nl
(024) 36 14934

Study Officials

  • Johan Blechert, M.Sc

    Cochlear Bone Anchored Solutions AB

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2014

First Posted

March 20, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 15, 2016

Results First Posted

January 11, 2016

Record last verified: 2016-01

Locations

GB(2)NL(1)SE(1)