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Trial registered on ANZCTR

Registration number

ACTRN12623000264684

Ethics application status

Approved

Date submitted

25/02/2023

Date registered

13/03/2023

Date last updated

28/07/2024

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Ureteric stone disease

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

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]

Treatment: Devices

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Immediately post-intervention commencement with KUB Xray

Secondary outcome [1]

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]

Immediately post-intervention commencement,

Secondary outcome [2]

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]

Immediately post-intervention commencement and then at definitive stone treatment operation (usually within 14-21 days).

Secondary outcome [3]

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]

Immediately post-intervention commencement,

Secondary outcome [4]

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]

At study completion.
We aim to complete within 6 months of study commencement.

Secondary outcome [5]

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]

After KUB X-ray to confirm position of the stent. This will usually be around 60 minutes post-intervention commencement,

Secondary outcome [6]

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]

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?

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

Recruiting

Date of first participant enrolment

Anticipated

4/12/2023

Actual

15/05/2024

Date of last participant enrolment

Anticipated

2/08/2024

Actual

Date of last data collection

Anticipated

30/08/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment hospital [2]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment postcode(s) [1]

3084 - Heidelberg

Recruitment postcode(s) [2]

3081 - Heidelberg West

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

JiffyStent Pty Ltd

Address [1]

5/210 Burgundy St
Heidelberg, VIC 3084

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health

Ethics committee address [1]

Level 8, HSB
Burgundy St
Heidelberg, 3084, VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/10/2023

Approval date [1]

24/04/2024

Ethics approval number [1]

HREC 92752

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

Dr Marlon Perera

Address

University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC

Country

Australia

Phone

+61 3 94574049

Fax

[email protected]

Contact person for public queries

Name

Marlon Perera

Address

University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC

Country

Australia

Phone

+61 3 94574049

Fax

[email protected]

Contact person for scientific queries

Name

Marlon Perera

Address

University of Melbourne, Austin Health
5/210 Burgundy ST
Heidelberg, 3084, VIC

Country

Australia

Phone

+61 3 94574049

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
23984	Study protocol	385223-(Uploaded-11-07-2024-10-39-45)-JiffyStent Protocol EDCIP-20100102-01_V2.0 (3).pdf
23985	Informed consent form	385223-(Uploaded-11-07-2024-10-40-05)-JIFFYSTENT_Austin Health OR Participant PICF_V1 Clean (3).pdf
23986	Informed consent form	385223-(Uploaded-11-07-2024-10-40-18)-JIFFYSTENT_Austin Health ED Participant PICF_V1 Clean.docx

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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No additional documents have been identified.

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