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Long Term Stability, Survival and Tolerability of a (Novel) Baha® Implant System

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ClinicalTrials.gov Identifier: NCT02092610
Recruitment Status : Completed
First Posted : March 20, 2014
Results First Posted : January 11, 2016
Last Update Posted : February 15, 2016
Sponsor:
Information provided by (Responsible Party):
Cochlear Bone Anchored Solutions

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Conductive Hearing Loss
Interventions: Device: Novel Implant BI300
Device: Standard Implant BI300

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Standard Implant BI300

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

Standard Implant BI300: 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

Novel Implant BI300

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.

Novel Implant BI300: 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.


Participant Flow:   Overall Study
    Standard Implant BI300   Novel Implant BI300
STARTED   25   52 
COMPLETED   17   40 
NOT COMPLETED   8   12 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Standard Implant BI300

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

Standard Implant BI300: 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

Novel Implant BI300

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.

Novel Implant BI300: 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.

Total Total of all reporting groups

Baseline Measures
   Standard Implant BI300   Novel Implant BI300   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   40   57 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   21   27 
>=65 years   11   19   30 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.2  (9.4)   55.4  (12.8)   63.2  (12.5) 
Gender 
[Units: Participants]
     
Female   7   21   28 
Male   10   19   29 
Region of Enrollment 
[Units: Participants]
     
Sweden   2   7   9 
Netherlands   11   26   37 
United Kingdom   4   7   11 
Implant stability measured by resonance frequence analysis [1] 
[Units: ISQ scores]
Mean (Standard Deviation)
 65.4  (3.2)   70.1  (2.4)   68.5  (3.4) 
[1] The ISQ value ranges from 1 to 100, the higher value, the higher the implant stabilty.


  Outcome Measures

1.  Primary:   Implant Stability   [ Time Frame: At the single 60 months visit ]

2.  Secondary:   Longterm Survival of Implant   [ Time Frame: At the single 60 months visit ]

3.  Secondary:   Soft Tissue Status   [ Time Frame: At the single 60 months visit ]

4.  Secondary:   Implant Survival   [ Time Frame: 60 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Myrthe Hol
Organization: Radboud University Hospital Nijmegen Medical Centre
phone: (024) 36 14934
e-mail: Myrthe.Hol@radboudumc.nl



Responsible Party: Cochlear Bone Anchored Solutions
ClinicalTrials.gov Identifier: NCT02092610     History of Changes
Other Study ID Numbers: CBAS5562
First Submitted: March 14, 2014
First Posted: March 20, 2014
Results First Submitted: October 26, 2015
Results First Posted: January 11, 2016
Last Update Posted: February 15, 2016