ANZCTR - Registration

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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]

NoneNone

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Vocal cord insufficiency

vocal cord paralysis

Condition category

Condition code

Surgery

Surgical techniques

Respiratory

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]

Treatment: Surgery

Intervention code [2]

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]

Patient reported voice-related quality of life measures
(VoiSS and perceived overall voice impairment on VAS)

Timepoint [1]

3, 6, and 12 months (primary timepoint) post-injection

Secondary outcome [1]

Vibratory properties measured on stroboscopy by a blinded, trained , independent rater

Timepoint [1]

pre-procedure
post-procedure at 1 week, 3 months, 6 months, 12 months

Secondary outcome [2]

Harmonic: noise ratio measured on Phontary Aerodynamic System Measurement tool

Timepoint [2]

pre-procedure,
3, 6, and 12 months from intervention

Secondary outcome [3]

phonation threshold pressure measured on Phontary Aerodynamic System Measurement tool

Timepoint [3]