Healthy SubjectsPhase 1NCT01862601
JetTouch Injection System to Deliver Saline Into the Bladder Wall of Healthy Volunteers
A Phase 1 study testing JetTouch Needle-free injection system in people with Healthy Subjects, run by American Medical Systems at 2 sites in United Kingdom.
Trial summary
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- JetTouch Needle-free injection system
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Sep 2013to Mar 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.
Who cannot join
- Unable or unwilling to sign Informed Consent Form or comply with study requirements
- Non-English speaking
- Currently enrolled in another clinical trial
- Undergone treatments given into the bladder in the past 4 weeks
- Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
- Female subject and is currently breast feeding
Show all 19Show fewer
- Female subject and has given birth in past 6 months
- Current or history of chronic urinary tract infections
- Current or history of chronic hematuria
- Current or history of bladder cancer
- History of major surgery in the last 6 months
- Current or history of bleeding disorders
- Currently taking anticoagulants
- Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
- Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
- Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
- Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
- Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
- Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Guy's Hospital / Quintiles, Ltd.
London, SE1 9RT
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield
About this study
Official title: Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.
- Conditions
- Healthy Subjects
- Being tested
- JetTouch Needle-free injection system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JetTouch Needle-free injection systemDevice
Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.
| Study group | Role | What they receive |
|---|---|---|
| JetTouch injections | Experimental | Not described Receives: Device: JetTouch Needle-free injection system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the JetTouch system to deliver saline into the bladder wall.
Measured: within 14 days of the JetTouch procedure
Ability of the JetTouch system to deliver saline into the bladder wall.
Measured: At the JetTouch procedure
Secondary outcomes (3)
Physician feedback on the use of the JetTouch system.
Measured: At the JetTouch Procedure
Physician feedback on perceived subject tolerability of the JetTouch injection procedure.
Measured: At the JetTouch procedure.
Subject feedback question regarding the procedure.
Measured: At the JetTouch procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Medical Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU, Principal investigator, Consultant Urological Surgeon, Royal Hallamshire Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862601
- Sponsor's protocol ID
- OT1202
- Status last verified
- May 2014
- First submitted
- 20 May 2013
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects
- ClinicalTrials.gov ID
- NCT01862601
- Acronym / sponsor ID
- OT1202
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- American Medical SystemsIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JetTouch injections | Experimental | Device: JetTouch Needle-free injection system |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.
Key exclusion criteria (19 listed)
- Unable or unwilling to sign Informed Consent Form or comply with study requirements
- Non-English speaking
- Currently enrolled in another clinical trial
- Undergone treatments given into the bladder in the past 4 weeks
- Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JetTouch Needle-free injection systemNeedle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall. | Device | JetTouch injections |
Primary outcome
Safety of the JetTouch system to deliver saline into the bladder wall.
Time frame: within 14 days of the JetTouch procedure
Ability of the JetTouch system to deliver saline into the bladder wall.
Time frame: At the JetTouch procedure
3 secondary outcomes
Physician feedback on the use of the JetTouch system.
Time frame: At the JetTouch Procedure
Physician feedback on perceived subject tolerability of the JetTouch injection procedure.
Time frame: At the JetTouch procedure.
Subject feedback question regarding the procedure.
Time frame: At the JetTouch procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher R Chapple, BSc MD DHC FRCS (Urol) FEBU principal investigator
Consultant Urological Surgeon, Royal Hallamshire Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JetTouch Needle-free injection system in people with Healthy Subjects, run by American Medical Systems at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the JetTouch system to deliver saline into the bladder wall. (time frame: within 14 days of the JetTouch procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2014.