Trial Outcomes & Findings for Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents (NCT NCT01975571)
NCT ID: NCT01975571
Last Updated: 2022-06-08
Results Overview
Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for children
Results posted on
2022-06-08
Participant Flow
Participant milestones
| Measure |
Adult
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents (L24)
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents S12
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant.
Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
5
|
0
|
|
Overall Study
COMPLETED
|
14
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hybrid Cochlear Implants in Severe to Profound Adults, Children, and Adolescents
Baseline characteristics by cohort
| Measure |
Adult
n=15 Participants
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents (L24)
n=5 Participants
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents S12
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant.
Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
5 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
15 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
52.5 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
13.04 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
—
|
42.6 years
STANDARD_DEVIATION 20.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
00 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: pre-op, 3, 6, 12, 24 months in the adults and pre-op, 3, 6, 12, 24, 36, 48, and 60 months post-implantation for childrenPopulation: adults study testing was completed at 24 months
Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) Testing will be in quiet at 60 dB(A). The CNC word perception test consists of multiple lists of 50 3-syllable words (consonant-nucleus-consonant) that are presented through a loudspeaker using an open set format. Percent correct is calculated by the number of words identified by the subject out of the 50 words presented.
Outcome measures
| Measure |
Adult
n=15 Participants
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents (L24)
n=5 Participants
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents S12
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant.
Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
|
|---|---|---|---|
|
Change in CNC Word Perception
baseline (pre-op)
|
27.6 percentage of words correct
Standard Error 4.4
|
34 percentage of words correct
Standard Error 5
|
—
|
|
Change in CNC Word Perception
6 months
|
63.5 percentage of words correct
Standard Error 6.4
|
64 percentage of words correct
Standard Error 9
|
—
|
|
Change in CNC Word Perception
3 months
|
55.9 percentage of words correct
Standard Error 6.6
|
68 percentage of words correct
Standard Error 7
|
—
|
|
Change in CNC Word Perception
12 months
|
66.7 percentage of words correct
Standard Error 6.0
|
69 percentage of words correct
Standard Error 7
|
—
|
|
Change in CNC Word Perception
24 months
|
70.5 percentage of words correct
Standard Error 7.5
|
67 percentage of words correct
Standard Error 61
|
—
|
|
Change in CNC Word Perception
36 months
|
—
|
61 percentage of words correct
Standard Error 14
|
—
|
|
Change in CNC Word Perception
48 months
|
—
|
62 percentage of words correct
Standard Error 18
|
—
|
|
Change in CNC Word Perception
60 months
|
—
|
65 percentage of words correct
Standard Error 19
|
—
|
SECONDARY outcome
Timeframe: Preoperatively and at 6 and 24 months post op in adults and pre op and 12 and 24 mos in childrenPopulation: patient time and no children in the S12 study
Pre-operatively and post-operative, testing will be conducted using bilaterally fitted devices (preoperatively) and a cochlear implant and bilateral hearing aids (if applicable) postoperatively (combined condition). Everyday sounds will be presented from one of eight loudspeakers at 60 dBA forming a 108- arc. The participant will face the center of the speaker array at a 1.4 m. 16 different sounds will be repeated 6 times and presented randomly from one of the loudspeakers. Localization performance was calculated by the average root-mean-square (RMS) error in degrees.
Outcome measures
| Measure |
Adult
n=15 Participants
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents (L24)
n=4 Participants
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents S12
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant.
Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
|
|---|---|---|---|
|
Change in Localization
preoperative (baseline)
|
23 RMS Error in Degrees
Standard Error 2.1
|
18 RMS Error in Degrees
Standard Error 2.1
|
—
|
|
Change in Localization
6 months
|
34 RMS Error in Degrees
Standard Error 1.8
|
26 RMS Error in Degrees
Standard Error 3.8
|
—
|
|
Change in Localization
12 months
|
32 RMS Error in Degrees
Standard Error 2.5
|
24 RMS Error in Degrees
Standard Error 3.2
|
—
|
SECONDARY outcome
Timeframe: Adults pre-op, 3, 6, 12, 24 months post opPopulation: protocol did not include testing on AzBio Sentences in noise with children/adolescents
Sentences in a +5 dB noise will be administered. Sentences will be tested at 60 dB(A) and noise at 55 dB(A) from the front. Pre-operatively, speech perception testing will be conducted using the ear implanted and bilaterally with appropriately fit hearing aids. Post-operatively, speech perception testing will be attempted in the following conditions (unless otherwise noted): Combined stimulation (cochlear implant and any hearing aids worn on the implanted or non-implanted ears) The AzBio sentence perception test consists of multiple lists of 20 sentences that are presented in sound-field from a loudspeaker using an open set format. Percent correct is calculated by the number of words correctly identified by the subject out of the total number of words presented in the sentence lists.
Outcome measures
| Measure |
Adult
n=15 Participants
Population 1: 15 Adults who have a severe sensorineural hearing loss with a pure-tone average (PTA) between 60-90 dB HL between 125-1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents (L24)
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold \>90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid L24 cochlear implant.
Cochlear® Nucleus™ Hybrid L24: The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
|
Children and Adolescents S12
Children (ages 5-12 years) and adolescents (ages 13-15 years) who have a sensorineural hearing loss with a pure-tone average (PTA) between 70-90 dB HL between 125-1500 Hz, a hearing threshold hearing threshold between 70-90 dB HL at 1500 Hz and profound loss at higher frequencies.
Intervention: These patients will receive a Hybrid S12 cochlear implant.
Cochlear® Nucleus™ Hybrid S12: The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
|
|---|---|---|---|
|
AzBio +5 Noise
3 months
|
26.4 percentage of words in sentence
Standard Error 4.9
|
—
|
—
|
|
AzBio +5 Noise
12 months
|
46.5 percentage of words in sentence
Standard Error 5.6
|
—
|
—
|
|
AzBio +5 Noise
preoperative (baseline)
|
14.6 percentage of words in sentence
Standard Error 5.04
|
—
|
—
|
|
AzBio +5 Noise
6 months
|
36.3 percentage of words in sentence
Standard Error 6.7
|
—
|
—
|
|
AzBio +5 Noise
24 months
|
51.4 percentage of words in sentence
Standard Error 7.8
|
—
|
—
|
Adverse Events
Adult
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children and Adolescents (L24)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Children and Adolescents S12
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place