Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000468628
Ethics application status
Approved
Date submitted
29/04/2014
Date registered
5/05/2014
Date last updated
2/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis - New Zealand
Scientific title
Safety and Efficacy Study of the ClariFix Cryoablation Device in Patients with Chronic Rhinitis
Secondary ID [1] 284497 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinitis 291749 0
Condition category
Condition code
Respiratory 292117 292117 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of cryoablation in the nasal passageway using a new cryosurgical device called the ClariFix Device. The ClariFix Device circulates liquid nitrous oxide through a closed-tip cryoprobe, where it is allowed to expand through a fine annular space. The transformation of the liquid into gas extracts heat from the surrounding areas by the Joule-Thompson effect. Either one or two treatments are delivered in each nasal cavity under endoscopic visualization, for a total of two to four treatments per patient. The treatment is delivered under local anesthesia. The total procedure time is approximately 30 minutes. The study procedure is performed only once per patient; there are no repeat procedures.
Intervention code [1] 289257 0
Treatment: Devices
Intervention code [2] 289288 0
Treatment: Surgery
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291997 0
Frequency of device- and procedure-related serious adverse events (SAEs) Adverse events will be assessed by patient interviews and physical examination and rhinoscopy at follow up visits. Examples of possible adverse events include infection, bleeding, pain, swelling, scarring, and sensory alterations.
Timepoint [1] 291997 0
Within 90 days post-treatment
Primary outcome [2] 291998 0
Efficacy endpoint: Change in nasal symptoms from baseline, using the four-symptom rTNSS (reflective Total Nasal Symptom Score)
Timepoint [2] 291998 0
90 days post-treatment
Secondary outcome [1] 307979 0
Impact on quality of life assessed by the Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ)
Timepoint [1] 307979 0
90 days post-treatment

Eligibility
Key inclusion criteria
a) Subject is >18 years of age
b) Subject has had moderate to severe symptoms of rhinorrhea and nasal congestion for >6 months (rTNSS rating of 2 or 3 for rhinorrhea and congestion)
c) Subject has signed EC-approved informed consent form
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Subject has clinically significant anatomic obstructions that limit access to the posterior nose including severe septal deviation, nasal polyps, and sinonasal tumor
b) Subject has a septal perforation
c) Subject has had prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose
d) Subject has had prior head or neck irradiation
e) Subject has active or chronic nasal or sinus infection
f) Subject has active coagulation disorder or patient is receiving anti-coagulants which cannot be safely stopped for 2 weeks
g) Subject has a history of dry eye or dry nose symptoms
h) Subject is pregnant
i) Subject is participating in another clinical research study
j) Subject has an allergy or intolerance to anesthetic agent
k) Subject is an active smoker or has been a smoker within the last 6 months
l) Any physical condition that in the investigator’s opinion would prevent adequate study participation or pose increased risk

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 6022 0
New Zealand
State/province [1] 6022 0

Funding & Sponsors
Funding source category [1] 289144 0
Commercial sector/Industry
Name [1] 289144 0
Arrinex, Inc.
Country [1] 289144 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Arrinex, Inc.
Address
1755 E. Bayshore Rd., Ste. 26A
Redwood City, CA 94063
Country
United States of America
Secondary sponsor category [1] 287809 0
None
Name [1] 287809 0
Address [1] 287809 0
Country [1] 287809 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290918 0
New Zealand Health and Disability Ethics Committee
Ethics committee address [1] 290918 0
Ethics committee country [1] 290918 0
New Zealand
Date submitted for ethics approval [1] 290918 0
08/05/2014
Approval date [1] 290918 0
10/06/2014
Ethics approval number [1] 290918 0
14/STH/58

Summary
Brief summary
Prior studies have shown that cryoablation in the nose improves nasal symptoms in patients with chronic rhinitis. This study is a prospective, non-randomized clinical study to assess the safety and effectiveness of the ClariFix Cryoablation Device when used to ablate unwanted tissue in the nose of patients with chronic rhinitis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47962 0
Dr Tom Kuruvilla
Address 47962 0
Tom Kuruvilla Limited
9 Caledonian Road
St Albans
Christchurch 8014
Country 47962 0
New Zealand
Phone 47962 0
+64 3 366 6733
Fax 47962 0
Email 47962 0
www.tomkuruvilla.co.nz
Contact person for public queries
Name 47963 0
Kristine Tatsutani
Address 47963 0
Arrinex, Inc.
1755 E. Bayshore Rd., Ste. 26A
Redwood City, CA 94063
Country 47963 0
United States of America
Phone 47963 0
+15105937546
Fax 47963 0
Email 47963 0
kristine@arrinex.com
Contact person for scientific queries
Name 47964 0
Kristine Tatsutani
Address 47964 0
Arrinex, Inc.
1755 E. Bayshore Rd., Ste. 26A
Redwood City, CA 94063
Country 47964 0
United States of America
Phone 47964 0
+15105937546
Fax 47964 0
Email 47964 0
kristine@arrinex.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.