Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000264684p
Ethics application status
Not yet submitted
Date submitted
25/02/2023
Date registered
13/03/2023
Date last updated
25/10/2023
Date data sharing statement initially provided
13/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study of the JiffyStent ureteric stent inserter for patients with acute renal colic requiring a ureteric stent.
Scientific title
A feasibility pilot study of the efficacy, reliability, safety and patient experience of the JiffyStent ureteric stent inserter.
Secondary ID [1] 308747 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ureteric stone disease 328688 0
Condition category
Condition code
Surgery 325698 325698 0 0
Surgical techniques
Renal and Urogenital 325699 325699 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A common presentation the emergency department is a patient in excruciating pain from a kidney stone obstructing the ureter and kidney. Many of these patients will require a ureteric stent to relieve the obstruction and their pain. The current best treatment is to admit these patients to the operating room and insert a stent with the patient under general anaesthetic. This process can take 24 hours or more. The JiffyStent is an innovative single use medical device that allows the Urologist or Emergency Department Physician to insert a ureteric stent while the patient is in the emergency room. This is a proof of concept study to show that the JiffyStent device works as desired by correctly inserting a stent into the ureters of patients, initially under controlled conditions in the operating room, and then in the emergency department. It is anticipated that use of the device will take 3-5 mins. If a stent cannot be inserted with the JiffyStent after the first attempt, then a stent will be inserted in the operating room by the standard procedure. The outcome of every JiffyStent case and the success of the stent insertion will be recorded by the trial team by medical record review and discussion with the treating doctor. The study will involve two phases: the first is 10 patients under controlled conditions in the operating room. These are patients who require a stent as a standard part of their urological procedure; the second phase is 40 patients who present to the emergency room with acute renal colic from a kidney stone and require a ureteric stent to be inserted. A successful outcome will lead to a pivotal multicentre clinical trial necessary for regulatory approval thereby making the JiffyStent device available for widespread use.
Intervention code [1] 325527 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333989 0
The ability of the JiffyStent to correctly insert a stent in to the ureter of a suitable patient as determined by post-stenting plain X-ray of the kidney.
Timepoint [1] 333989 0
Immediately post-intervention commencement with KUB Xray
Secondary outcome [1] 418958 0
The mechanical reliability of the JiffyStent to perform its function correctly as determined by the treating doctor as noted on a global doctor satisfaction score.
Timepoint [1] 418958 0
Immediately post-intervention commencement,
Secondary outcome [2] 418959 0
The clinical safety of the JiffyStent.
Outcome assessed using adverse events as noted by the doctor on a study-specific questionnaire, and follow-up at definitive stone treatment operation (usually 14-21 days later) with data-linkage to medical records and patient questionnaire. Adverse events such as infection, haematuria. excess stent pain will be noted.
Timepoint [2] 418959 0
Immediately post-intervention commencement and then at definitive stone treatment operation (usually within 14-21 days).
Secondary outcome [3] 418960 0
Time taken to insert the ureteric stent using JiffyStent device. This will be measured with a stop watch or doctor's best estimate and recorded on a case report form.
Timepoint [3] 418960 0
Immediately post-intervention commencement,
Secondary outcome [4] 418961 0
Feasibility- evaluation of patient recruitment rate.
A log will be kept of all patients invited to the study and if applicable, their reasons for refusal noted. Feasibility will be assessed using recruitment/withdrawal data and an audit of study enrolment and withdrawal logs.
Timepoint [4] 418961 0
At study completion.
We aim to complete within 6 months of study commencement.
Secondary outcome [5] 418962 0
Patient experience and satisfaction with the JiffyStent medical device.
Patients will receive a written questionnaire specifically designed for this study regarding their experience of ureteric stent insertion with the JiffyStent device. It will utilise a visual analog score for pain/discomfort and a rating system for overall experience.
Timepoint [5] 418962 0
After KUB X-ray to confirm position of the stent. This will usually be around 60 minutes post-intervention commencement,
Secondary outcome [6] 418963 0
Engagement and acceptability to surgical, medical and nursing hospital staff.
This will be semi-structured ono-on-one face-to-face interviews with doctors and nurses in the emergency department involved in cases, as well as doctors and members of the research team,
Timepoint [6] 418963 0
6 months post-intervention commencement,

Eligibility
Key inclusion criteria
• Consenting adult patients adult male or female, age greater than or equal to 18 years old.
• Patient about to undergo stent insertion as part of their routine urological care (phase one), or
• Patient who has presented to the emergency department with acute renal colic requiring admission to hospital for a ureteric stent (phase two)
• Ability to provide informed consent signed by study patient
• Willingness and ability to comply with study-related procedures/assessments
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Age <18
• Allergy to local anaesthetic lubricating gel
• Stone larger than 1cm
• Stone impacted in ureter
• Men with prostate larger than 100cc in size
• Patient with severe sepsis requiring nephrostomy or stabilsation in an operating room

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/12/2023
Actual
Date of last participant enrolment
Anticipated
2/02/2024
Actual
Date of last data collection
Anticipated
1/03/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24131 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 24132 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 39643 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 39642 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 312967 0
Commercial sector/Industry
Name [1] 312967 0
JiffyStent Pty Ltd
Country [1] 312967 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
JiffyStent Pty Ltd
Address
5/210 Burgundy St
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 314657 0
None
Name [1] 314657 0
Address [1] 314657 0
Country [1] 314657 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 312239 0
Austin Health
Ethics committee address [1] 312239 0
Level 8, HSB
Burgundy St
Heidelberg, 3084, VIC
Ethics committee country [1] 312239 0
Australia
Date submitted for ethics approval [1] 312239 0
30/10/2023
Approval date [1] 312239 0
Ethics approval number [1] 312239 0

Summary
Brief summary
Pain from a kidney stone is excruciating. Many people who present to an emergency department with kidney stone pain require admission to hospital and a trip to the operating room to insert a stent to help relieve the pain. The JiffyStent is an innovative medical device that allows the insertion of a ureteric stent in the emergency department without the prolonged wait and need to go to the operating room. This is a proof of concept pilot study to show that the JiffyStent device is able to quickly and correctly insert a stent into the ureters of patients while they are still in the emergency department. A successful outcome will lead to a pivotal multicentre clinical trial necessary for regulatory approval thereby making the JiffyStent device available for widespread use.
Trial website
Trial related presentations / publications
Public notes
Acute renal colic is the sudden onset of severe flank pain mainly caused by the obstruction of the urinary tract by the presence of a stone. Nephrolithiasis or kidney stones is a common condition with prevalence rates of 5% - 15% in the population. Yearly incidence in North America and Europe is 0.5%. It is most likely to occur in patients between the ages of 20 and 50. More likely in men than women by a factor of 2:1. Risk factors include obesity, hypertension, family history, IBS, and diabetes.

Causes

Pain is often caused by a combination of ureteral muscle spasms, increased proximal peristalsis, localized inflammatory changes, renal swelling with capsular stretching, edema, and irritation. These, in turn, stimulate submucosal stretch receptors in the ureter, renal pelvis, and capsule. Stimulation of the renal pelvis, peripelvic renal capsule, and calices from stretching most closely mimic renal colic.

Factors Associated with Surgical Intervention

Factors associated with earlier surgical intervention are - severe hydronephrosis; ureteral stone >8mm; >700 Hounsfield units stone density; >0.2 cc stone volume; >2mm ureteral wall thickness; extrarenal pelvis; anterior-posterior diameter of renal pelvis >18mm.
Up to 95% of stones >8mm require intervention to pass. Patients with infected stones need operative intervention to prevent repeat infection or stone formation.

Current Standard of Care

The current standard treatment for patients presenting to the emergency department with acute renal colic due to an obstructing ureteric stone is to give them pain relief, admit them to hospital, and then find a time in the operating room to insert a stent. This operating slot may be on a regular list or on the emergency operating list. Patients will often wait over 24 hours to have their stent inserted in the operating room with all the burden of prolonged fasting, recurrent pain, prolonged obstruction of the kidney with risk of kidney impairment, infection, and time away from home.

JiffyStent ureteric stent inserter solution

The all-in-one single use JiffyStent device allows visualization of the ureteric orifice and subsequent insertion of a pre-loaded ureteric stent into the ureter for the purpose of alleviating ureteric or renal obstruction due to an acute ureteric stone. The value of the Jiffystent is that it will rapidly alleviate the patient’s pain without the need to go to the operating room. This will significantly reduce the time the patient experiences pain; reduce burden on emergency department waiting times for hospital beds; reduce opportunity costs for emergency operating lists; reduce the inconvenience to surgeons waiting prolonged periods for emergency operating slots (often very late at night); markedly reduce the cost of treating ureteric stones for the health system.

Contacts
Principal investigator
Name 123950 0
Dr Marlon Perera
Address 123950 0
University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC
Country 123950 0
Australia
Phone 123950 0
+61 3 94574049
Fax 123950 0
Email 123950 0
marlon.perera@austin.org.au
Contact person for public queries
Name 123951 0
Dr Marlon Perera
Address 123951 0
University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC
Country 123951 0
Australia
Phone 123951 0
+61 3 94574049
Fax 123951 0
Email 123951 0
marlon.perera@austin.org.au
Contact person for scientific queries
Name 123952 0
Dr Marlon Perera
Address 123952 0
University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC
Country 123952 0
Australia
Phone 123952 0
+61 3 94574049
Fax 123952 0
Email 123952 0
marlon.perera@austin.org.au

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?

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.