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Cystoscopic Ablation Via RF Energy Clinical Trial (CARETI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398578
Recruitment Status : Terminated (Company closed May 1, 2019)
First Posted : March 25, 2015
Last Update Posted : May 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amphora Medical, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Device: Amphora OAB Device Phase 1 Phase 2

Detailed Description:
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cystoscopic Ablation Via RF Energy Clinical Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : April 30, 2019
Actual Study Completion Date : April 30, 2019

Arm Intervention/treatment
Experimental: Amphora OAB Device
Specialized cystoscope that facilitates visualization and radiofrequency (RF) therapy for the treatment of OAB.
Device: Amphora OAB Device
Cystoscopic procedure to treat OAB




Primary Outcome Measures :
  1. Device-related complications through 24 month follow-up [ Time Frame: 24 month ]

Secondary Outcome Measures :
  1. Device Technical Success [ Time Frame: During the study procedure ]
  2. Procedural Success [ Time Frame: During the study procedure ]
  3. Change from Baseline of Quality of Life Scores [ Time Frame: 4 weeks, 12 weeks, 6, 12, 18, and 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subjects must meet ALL the inclusion criteria to be eligible to participate in the study.

  1. Non-pregnant, non-lactating female > 18 years old with a history of idiopathic OAB for ≥ 6 months
  2. Have failed or are not a candidate for drug treatment
  3. 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
  4. Ambulatory without the aid of walking assistance a majority of the time (cane, walker etc.) and able to use toilet without assistance
  5. 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.
  6. Ability and willingness to self-catheterize in case this is necessary
  7. 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)

Exclusion Criteria

Subject will be excluded if ANY of the following conditions apply:

  1. Planning on becoming pregnant during the 12 month study period
  2. Current participation in any other conflicting interventional or OAB treatment study
  3. Primary complaint of stress urinary incontinence or stress predominant mixed incontinence or functional incontinence
  4. Any invasive or surgical intervention (e.g., radio frequency, implant, sling) involving the bladder, rectum or vaginal wall within the last 6 months
  5. Ongoing complications of prior anti-incontinence surgery
  6. Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period
  7. 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

  8. Botox treatment for OAB with 100u in the last 6 months OR Botox treatment with >100u in last 9 months
  9. 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.
  10. Documented spontaneous unprovoked urinary retention within the last 6 months
  11. 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
  12. Current bleeding disorder or coagulopathies
  13. 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.
  14. Subject has been previously diagnosed with interstitial cystitis, bladder cancer or chronic pelvic pain syndrome.
  15. Previous pelvic irradiation
  16. Serum creatinine > twice the upper limit of normal within the last six months
  17. Neurological disease affecting bladder function such as multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease
  18. Current hydronephrosis or hydroureter
  19. Bladder outflow obstruction
  20. Ureteral dysfunction, stricture or reflux

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02398578


Locations
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Belgium
University of Antwerp
Antwerp, Belgium
University Hospital Ghent
Ghent, Belgium
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada
Canada, Quebec
University of Sherbrooke
Sherbrooke, Quebec, Canada
Sponsors and Collaborators
Amphora Medical, Inc.
Investigators
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Principal Investigator: Roger Demochowski, MD Vanderbilt University
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Responsible Party: Amphora Medical, Inc.
ClinicalTrials.gov Identifier: NCT02398578    
Other Study ID Numbers: 1135-01
First Posted: March 25, 2015    Key Record Dates
Last Update Posted: May 7, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations