Cystoscopic Ablation Via RF Energy Clinical Trial (CARET 2)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02480829
Recruitment Status : Recruiting
First Posted : June 25, 2015
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
Amphora Medical, Inc.

Brief Summary:
Two Phase Multicenter Study to Evaluate Safety and Efficacy 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 3.0 mm Phase 1 Phase 2

Detailed Description:
The study will enroll subjects with symptomatic idiopathic overactive bladder (OAB). Subjects who are found to be unresponsive to or intolerant of medical therapy will be screened and evaluated for suitability for study participation. A 3 day Bladder Diary must be completed to verify enrollment eligibility.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cystoscopic Ablation Via RF Energy Clinical Trial (CARET 2)
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Amphora OAB Device 3.0 mm
Treatment with the Amphora OAB Device
Device: Amphora OAB Device 3.0 mm
Treatment with the Amphora OAB Device

Primary Outcome Measures :
  1. Device-Related Serious Complications [ Time Frame: 4 weeks ]
    Number of patients with Serious Complications based on reported Adverse Events

Information from the National Library of Medicine

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

Subjects must meet ALL the inclusion criteria to be eligible to participate

  1. Non-pregnant, non-lactating female at least 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 visit 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.
  6. Ability and willingness to self-catheterize in case this is necessary
  7. Bladder Diary Criteria: over the 3 days the following outcomes:

    • Micturition frequency of ≥ 8 times/day, on average
    • AND > 3 episodes of urgency urinary incontinence (UUI)

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

  1. Planning on becoming pregnant during the 18 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 involving the bladder, rectum or vaginal wall (e.g., radio frequency, implant, sling) within the last 6 months
  5. Ongoing complications of prior anti-incontinence surgery
  6. SNS or PTNS treatment within the last 15 days. NOTE: a SNS device that is not turned on is acceptable for enrollment
  7. Botox treatment for OAB with 100u in the last 6 months OR Botox treatment with >100u in last 9 months.
  8. Subject with 24-hour total urine volume voided greater than 3,000 ml as measured at screening period
  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 or surgical implants that, in the opinion of the investigator, would preclude the introduction and/or use of the device such as significant pelvic organ prolapse, urogenital prolapse visible at rest beyond the hymen, significant cystocele prolapse, implanted vaginal mesh between the trigone of the bladder and vagina or high BMI.
  12. Current hydronephrosis or hydroureter
  13. Current bleeding disorder or coagulopathies
  14. 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.
  15. Subject has been previously diagnosed with bladder cancer or has a current diagnosis of interstitial cystitis or chronic pelvic pain syndrome.
  16. Previous pelvic irradiation
  17. Serum creatinine or BUN > twice the upper limit of normal within the last sixty days
  18. Neurological disease affecting bladder function such as multiple sclerosis, spinal cord injuries, myasthenia gravis, Charcot-Marie-Tooth disease
  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 identifier (NCT number): NCT02480829

Contact: Amphora Medical 763-220-3730

United States, New York
Premier Medical Group of the Hudson Valley Recruiting
Poughkeepsie, New York, United States, 12601
United States, South Dakota
Sanford Female Pelvic Medicine and Reconstructive Surgery Recruiting
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Amphora Medical, Inc.
Principal Investigator: Eric Rovner, MD Medical University of South Carolina

Responsible Party: Amphora Medical, Inc. Identifier: NCT02480829     History of Changes
Other Study ID Numbers: 1220-001
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: June 2016

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms