Trial Outcomes & Findings for Clinical Investigation of the Nucleus® CI532 Cochlear Implant (NCT NCT02392403)

NCT ID: NCT02392403

Last Updated: 2018-11-01

Results Overview

The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: up to one month post-surgery
• Results posted on: 2018-11-01

Participant Flow

Participant milestones

Measure	Nucleus CI532 Cochlear Implant Single arm study. All participants received CI532.
Overall Study STARTED	45
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Nucleus CI532 Cochlear Implant Single arm study. All participants received CI532.
Overall Study Adverse Event	1
Overall Study Death	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Clinical Investigation of the Nucleus® CI532 Cochlear Implant

Baseline characteristics by cohort

Measure	Nucleus CI532 Cochlear Implant n=45 Participants Single arm study. All participants received CI532.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	61 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to one month post-surgery

Population: One patient was explanted and reimplanted with a different type of device.

The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=44 Participants Single arm study. All participants received CI532.
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan Completely in scala tympani	44 Participants
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan Dislocation in scala vestibuli	0 Participants

SECONDARY outcome

Timeframe: up to one month post-surgery

The ratio of the active array length and the corresponding lateral wall length

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=44 Participants Single arm study. All participants received CI532.
Array Proximity to the Modiolus Measured Using the Wrapping Factor	0.62 ratio Standard Deviation 0.05

SECONDARY outcome

Timeframe: at time of surgery

To collect experiences using the CI532. At each surgery, the surgeon was asked whether "overall the CI532 was easy to handle and the EA32 easy to insert". We counted the number of surgeons who strongly agreed or who agreed.

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=45 Participants Single arm study. All participants received CI532.
Surgeon Questionnaire on Implant Surgery	38 Surgeons

SECONDARY outcome

Timeframe: baseline and 6 months post activation

Change in percent correct speech recognition test scores for implant ear alone and best aided

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=44 Participants Single arm study. All participants received CI532.
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months Quiet Implant Ear	52.500 Percent correct Interval 25.0 to 71.8
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months Quiet Best Aided	29.668 Percent correct Interval 12.5 to 56.0
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months 10 db Signal-to-Noise Ratio (SNR) Implant Ear	63.725 Percent correct Interval 5.6 to 88.2
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months 10 db Signal-to-Noise Ratio (SNR) Best Aided	33.690 Percent correct Interval 2.5 to 63.2

SECONDARY outcome

Timeframe: 6 months post activation

The Glasgow Benefit Inventory is a single time point measure of patient reported benefit.

A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=42 Participants Single arm study. All participants received CI532.
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire	28.1 units on a scale Interval 21.577 to 34.738

SECONDARY outcome

Timeframe: baseline and 6 months post activation

Rating scale. 0=worst; 10=best

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=41 Participants Single arm study. All participants received CI532.
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months	2.22 units on a scale Interval 1.695 to 2.75

SECONDARY outcome

Timeframe: baseline and 6 months post activation

Population: Note that some patients had no measurable pre-operative hearing

We report only the change for the 500 Hz frequency.

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=36 Participants Single arm study. All participants received CI532.
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months	20 Decibels Interval 5.0 to 40.0

SECONDARY outcome

Timeframe: at time of surgery

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=45 Participants Single arm study. All participants received CI532.
Number of Adverse Events at Surgery	3 adverse events

SECONDARY outcome

Timeframe: post surgery to 6 months post-activation

Outcome measures

Measure	Nucleus CI532 Cochlear Implant n=45 Participants Single arm study. All participants received CI532.
Number of Adverse Events Post Surgery to 6 Months Post-activation	32 adverse events

Adverse Events

Nucleus CI532 Cochlear Implant

Serious events: 4 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Measure	Nucleus CI532 Cochlear Implant n=45 participants at risk Single arm study. All participants received CI532.
Ear and labyrinth disorders Prolonged hospitalization for re-implantation	4.4% 2/45 • Number of events 2 • 16 months
Cardiac disorders Death due to myocardial infarction	2.2% 1/45 • Number of events 1 • 16 months
General disorders Hospitalization for hysterectomy and bladder wall reinforcement	2.2% 1/45 • Number of events 1 • 16 months

Other adverse events

Measure	Nucleus CI532 Cochlear Implant n=45 participants at risk Single arm study. All participants received CI532.
Ear and labyrinth disorders Tinnitus	15.6% 7/45 • Number of events 7 • 16 months
General disorders Pain	24.4% 11/45 • Number of events 11 • 16 months
Ear and labyrinth disorders Dizziness and/or vertigo	17.8% 8/45 • Number of events 8 • 16 months
Gastrointestinal disorders Nausea	8.9% 4/45 • Number of events 4 • 16 months

Additional Information

Chris James

Cochlear

Phone: +33 534 638 584

Email: cjames@cochlear.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator agrees to send any Conference presentations/publications to the Sponsor for review at least 30 days prior to publication/presentation and after the first publication has been submitted. The Sponsor has the right to require any confidential information to be removed. If there is intellectual property disclosed, which the Sponsor intends to protect by registration such as by patent application, the Sponsor may require the release of the publication to be delayed by up to 120 days.
• Publication restrictions are in place

Restriction type: OTHER