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Trial registered on ANZCTR


Registration number
ACTRN12620000451909p
Ethics application status
Not yet submitted
Date submitted
22/12/2019
Date registered
6/04/2020
Date last updated
6/04/2020
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Nanofat: a novel therapeutic approach for vocal cord paralysis
Scientific title
Effect of nanofat injection for vocal cord paralysis on voice-related quality of life and stroboscopic measures
Secondary ID [1] 299184 0
NoneNone
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vocal cord insufficiency 314284 0
vocal cord paralysis 316806 0
Condition category
Condition code
Surgery 312634 312634 0 0
Surgical techniques
Respiratory 315137 315137 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nanofat involves mechanically emulsifying and filtering harvested fat. The technique does not require the use of a surgical laboratory, proteolytic enzyme reagents, or specialised equipment. Studies have shown nanofat to contain stromal vascular fraction (SVF) - a non-adipocyte, supportive component of harvested fat and contains a complex population of fibroblasts, macrophages, immune regulatory cells, and a high density of adipocyte-derived stem cells (ADSC).

This study will look at vocal fold paralysis. Patients will be randomised to either autologous fat injection (fat harvested from the patient and injected to the paralysed cord) only or autologous fat plus autologous nanofat injection.

The senior researcher (PP, ENT surgeon) will perform all injections.
All injections would take place at a tertiary hospital setting in an operating theatre under general anaesthetic.
Fat is processed on-site to isolate cells. The sieving process will be the same as the technique already described in the literature by Tonnard et al. The harvested fat will be mechanically emulsified by shifting the sample between two 10-mL syringes connected to each other by Luer-Lok connection. The fat then becomes an emulsion after 30 passes. Following the emulsification process, the liquid is filtered for injection. The harvesting process should take no longer than 30 minutes. All injections occur under general anaesthetic and direct microlaryngoscopy. The entire procedure should be completed in one hour. The harvest and intervention administration occurs under the same anaesthetic.

The dose administered is difficult to be quantified. This is because different patients will have different degrees of vocal cord lateralisation in addition to other anatomic factors (bulk required to medialise vocal cord, size, length, etc). In addition, it is also difficult to quantify the amount of grafted fat exactly, because some may extrude from the injection site after removing the needle. In general, a total of 0.5 to 2 mL of nanofat will be injected. The amount injected at the time of the procedure will be recorded by the operator.
Intervention code [1] 315476 0
Treatment: Surgery
Intervention code [2] 316868 0
Treatment: Other
Comparator / control treatment
Comparator treatment:
The researchers will compare the effects of nanofat injection to medialise the paralysed vocal fold versus autologous fat injection to the paralysed cord. The comparator group in this arm is standard of care treatment (autologous fat injection).

The harvesting process takes no longer than 30 minutes. All injections occur under general anaesthetic and direct microlaryngoscopy. The entire procedure should be completed in one hour. The harvest and intervention administration occurs under the same anaesthetic.

The dose administered is difficult to be quantified. This is because different patients will have different degrees of vocal cord lateralisation in addition to other anatomic factures (bulk required to medialise vocal cord, size, length, etc). In addition, it is also difficult to quantify the amount of grafted fat exactly, because some may extrude from the injection site after removing the needle.

The senior researcher will harvest and administer the injection (ENT surgeon). The comparator treatment is autologous fat only (no nanofat injection)
Control group
Active

Outcomes
Primary outcome [1] 321285 0
Patient reported voice-related quality of life measures
(VoiSS and perceived overall voice impairment on VAS)
Timepoint [1] 321285 0
3, 6, and 12 months (primary timepoint) post-injection
Secondary outcome [1] 374535 0
Vibratory properties measured on stroboscopy by a blinded, trained , independent rater
Timepoint [1] 374535 0
pre-procedure
post-procedure at 1 week, 3 months, 6 months, 12 months
Secondary outcome [2] 380158 0
Harmonic: noise ratio measured on Phontary Aerodynamic System Measurement tool
Timepoint [2] 380158 0
pre-procedure,
3, 6, and 12 months from intervention
Secondary outcome [3] 380159 0
phonation threshold pressure measured on Phontary Aerodynamic System Measurement tool
Timepoint [3] 380159 0
Pre-procedure
3, 6, and 12 months post-procedure
Secondary outcome [4] 380160 0
Subglottic pressure measured on Phontary Aerodynamic System Measurement tool
Timepoint [4] 380160 0
Pre-procedure
3, 6, and 12 months post-procedure
Secondary outcome [5] 381420 0
Perturbation measured on stroboscopy
Timepoint [5] 381420 0
Pre-procedure
3, 6, and 12 months post-procedure
Secondary outcome [6] 381421 0
fundamental frequency measured on stroboscopy
Timepoint [6] 381421 0
Pre-procedure
3, 6, and 12 months post-procedure
Secondary outcome [7] 381422 0
intensity measured on stroboscopy
Timepoint [7] 381422 0
Pre-procedure
3, 6, and 12 months post-procedure
Secondary outcome [8] 381423 0
s:z ratio measured on stroboscopy
Timepoint [8] 381423 0
Pre-procedure
3, 6, and 12 months post-procedure

Eligibility
Key inclusion criteria
unilateral vocal cord paralysis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
evidence of other vocal fold abnormalities (granuloma, polyps, sulcus or other pathology affecting vocal fold vibration), previous history of glottic cancer, previous laser resection of the vocal fold, prior radiotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 303725 0
Hospital
Name [1] 303725 0
Monash Health
Country [1] 303725 0
Australia
Primary sponsor type
Hospital
Name
Department of Otolaryngology, Monash Health
Address
Department of ENT
823-65 Centre Road
Bentleigh East VIC 3165
Country
Australia
Secondary sponsor category [1] 304878 0
None
Name [1] 304878 0
Address [1] 304878 0
Country [1] 304878 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 304250 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 304250 0
246 Clayton Road
Clayton VIC 3168
Ethics committee country [1] 304250 0
Australia
Date submitted for ethics approval [1] 304250 0
30/04/2020
Approval date [1] 304250 0
Ethics approval number [1] 304250 0

Summary
Brief summary
Glottic insufficiency can have negative effects on patient quality of life. This condition mainly affects the quality and strength of voice. Glottic insufficiency can be due to vocal cord paralysis. Autologous fat injection is a well-known technique used to manage paralysis, and has been utilised for many years as a valid technique. A new method of processing fat has been described whereby harvested fat can be processed and filtered quickly and efficiently, leaving behind an easily injectable liquid with a high number of stem cells, without requiring long processing times and highly specialised equipment. It is potentially a modern refinement and improvement of a long-standing technique.
The proposed benefit of nanofat supplementation is that the volume of the injected cord is maintained for longer compared to fat grafting alone. due to increased adipocyte survival.
Patients will be recruited to undergo nanofat injection for vocal fold paralysis. Prior to the surgery, patients will fill out questionnaires and have their vocal cords examined via stroboscopy and undergo objective acoustic and aerodynamic assessment. They will then undergo treatment with follow up assessments occurring at multiple timepoints thereafter, as described in our protocol. The effect of nanofat treatment will be compared with standard of care treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96286 0
Dr Daniel Wong
Address 96286 0
Monash Health
Department of ENT
Rear 867 Centre Rd
Bentleigh East 3165 VIC
Country 96286 0
Australia
Phone 96286 0
+61 39928 8799
Fax 96286 0
Email 96286 0
[email protected]
Contact person for public queries
Name 96287 0
Debra Phyland
Address 96287 0
Monash Health
Department of ENT
Rear 867 Centre Rd
Bentleigh East 3165 VIC
Country 96287 0
Australia
Phone 96287 0
+61 39928 8799
Fax 96287 0
Email 96287 0
[email protected]
Contact person for scientific queries
Name 96288 0
Paul Paddle
Address 96288 0
Monash Health
Department of ENT
Rear 867 Centre Rd
Bentleigh East 3165 VIC
Country 96288 0
Australia
Phone 96288 0
+6139928 8799
Fax 96288 0
Email 96288 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6258Study protocol    378307-(Uploaded-22-12-2019-22-54-17)-Study-related document.pdf
7417Ethical approval    Ethical approval is being obtained through the Mon... [More Details]



Results publications and other study-related documents

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Documents added automatically
No additional documents have been identified.