Overactive BladderPhase 1/2CARETINCT02398578
Cystoscopic Ablation Via RF Energy Clinical Trial
A Phase 1/2 study testing Amphora OAB Device in people with Overactive Bladder, run by Amphora Medical, Inc. at 4 sites in 2 countries.
Trial summary
Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Amphora OAB Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Feb 2015to 30 Apr 2019
- Phase
- Phase 1/2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet ALL the inclusion criteria to be eligible to participate in the study.
- Non-pregnant, non-lactating female > 18 years old with a history of idiopathic OAB for ≥ 6 months
- Have failed or are not a candidate for drug treatment
- Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow up visits and testing schedules
- Ambulatory without the aid of walking assistance a majority of the time (cane, walker etc.) and able to use toilet without assistance
- Post-void residual (PVR) ≤ 100 ml NOTE: Subjects with a single PVR of >100 ml followed by two consecutive PVR measurements of ≤100 ml may be included in the study. The final acceptable PVR measurement will be recorded in the data.
- Ability and willingness to self-catheterize in case this is necessary
- 3 day Bladder Diary Criteria: Symptoms of OAB as evidenced by: Micturition frequency of ≥ 8 times/day And > 3 episodes of urgency urinary incontinence (UUI)
Who cannot join
- Subject will be excluded if ANY of the following conditions apply:
- Planning on becoming pregnant during the 12 month study period
- Current participation in any other conflicting interventional or OAB treatment study
- Primary complaint of stress urinary incontinence or stress predominant mixed incontinence or functional incontinence
- Any invasive or surgical intervention (e.g., radio frequency, implant, sling) involving the bladder, rectum or vaginal wall within the last 6 months
- Ongoing complications of prior anti-incontinence surgery
Show all 22Show fewer
- Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period
- Receiving electro-stimulation (e.g. PTNS or SNS) treatment within the last 15 days.
- NOTE: Subjects with an implanted SNS device that has not been active in the last 15 days is acceptable for enrollment
- Botox treatment for OAB with 100u in the last 6 months OR Botox treatment with >100u in last 9 months
- Urinary tract infection that is not resolved at the time of enrollment or had > 3 urinary tract infections (UTIs) within the last 12 months NOTE: If UTI is present at baseline screening, treatment with antibiotics and a negative urinalysis at least 7 days after the initial diagnosis of UTI will be acceptable for enrollment.
- Documented spontaneous unprovoked urinary retention within the last 6 months
- Anatomical conditions that would preclude the introduction and use of the device, in the opinion of the investigator, such as significant pelvic organ prolapse, urogenital prolapse visible at rest beyond the hymen, significant cystocele prolapse or high BMI
- Current bleeding disorder or coagulopathies
- Current use of antimuscarinics, β3 agonist or antispasmodics NOTE: subjects on these drugs must undergo a 2 week washout period prior to completing the baseline Bladder Diary.
- Subject has been previously diagnosed with interstitial cystitis, bladder cancer or chronic pelvic pain syndrome.
- Previous pelvic irradiation
- Serum creatinine > twice the upper limit of normal within the last six months
- Neurological disease affecting bladder function such as multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease
- Current hydronephrosis or hydroureter
- Bladder outflow obstruction
- Ureteral dysfunction, stricture or reflux
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Canada2 sites
University of Calgary
Calgary, Alberta
University of Sherbrooke
Sherbrooke, Quebec
About this study
Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder.
Read the detailed description
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).
- Conditions
- Overactive Bladder
- Being tested
- Amphora OAB Device
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amphora OAB DeviceDevice
Cystoscopic procedure to treat OAB
| Study group | Role | What they receive |
|---|---|---|
| Amphora OAB Device | Experimental | Specialized cystoscope that facilitates visualization and radiofrequency (RF) therapy for the treatment of OAB. Receives: Device: Amphora OAB Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device-related complications through 24 month follow-up
Measured: 24 month
Secondary outcomes (3)
Device Technical Success
Measured: During the study procedure
Procedural Success
Measured: During the study procedure
Change from Baseline of Quality of Life Scores
Measured: 4 weeks, 12 weeks, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Why it stopped: Company closed May 1, 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amphora Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Demochowski, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398578
- Sponsor's protocol ID
- 1135-01
- Acronym
- CARETI
- Status last verified
- May 2019
- First submitted
- 12 Jan 2015
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cystoscopic Ablation Via RF Energy Clinical Trial
- ClinicalTrials.gov ID
- NCT02398578
- Acronym / sponsor ID
- CARETI / 1135-01
- Conditions
- Overactive Bladder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company closed May 1, 2019
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Amphora Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2015 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 25 Mar 2015 (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.
Phase I/II study to assess the safety and performance of the Amphora OAB system for treatment of urgency and frequency with or without urge incontinence caused by an overactive bladder.
Detailed description
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amphora OAB Device | Experimental | Device: Amphora OAB DeviceSpecialized cystoscope that facilitates visualization and radiofrequency (RF) therapy for the treatment of OAB. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects must meet ALL the inclusion criteria to be eligible to participate in the study.
- Non-pregnant, non-lactating female > 18 years old with a history of idiopathic OAB for ≥ 6 months
- Have failed or are not a candidate for drug treatment
- Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow up visits and testing schedules
- Ambulatory without the aid of walking assistance a majority of the time (cane, walker etc.) and able to use toilet without assistance
Key exclusion criteria (22 listed)
- Planning on becoming pregnant during the 12 month study period
- Current participation in any other conflicting interventional or OAB treatment study
- Primary complaint of stress urinary incontinence or stress predominant mixed incontinence or functional incontinence
- Any invasive or surgical intervention (e.g., radio frequency, implant, sling) involving the bladder, rectum or vaginal wall within the last 6 months
- Ongoing complications of prior anti-incontinence surgery
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 |
|---|---|---|
| Amphora OAB DeviceCystoscopic procedure to treat OAB | Device | Amphora OAB Device |
Primary outcome
Device-related complications through 24 month follow-up
Time frame: 24 month
3 secondary outcomes
Device Technical Success
Time frame: During the study procedure
Procedural Success
Time frame: During the study procedure
Change from Baseline of Quality of Life Scores
Time frame: 4 weeks, 12 weeks, 6, 12, 18, and 24 months
Results and safety
The study was stopped early (reason given: Company closed May 1, 2019). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
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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.
Roger Demochowski, MD principal investigator
Vanderbilt University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Amphora OAB Device in people with Overactive Bladder, run by Amphora Medical, Inc. at 4 sites in 2 countries.
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 8 inclusion and 22 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: stopped early, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Canada. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Company closed May 1, 2019). Results are not available in the source record.
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?
Device-related complications through 24 month follow-up (time frame: 24 month). 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 7 May 2019.