Trial record 1 of 1 for:
calyxo
Comparison of Laser Lithotripsy With and Without Steerable Ureteroscopic Renal Evacuation (SURE)
|
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: NCT04519294 |
|
Recruitment Status :
Active, not recruiting
First Posted : August 19, 2020
Last Update Posted : March 6, 2023
|
Sponsor:
Calyxo, Inc.
Information provided by (Responsible Party):
Calyxo, Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The purpose of the study is to compare the effects, good and/or bad, of a treatment for removing kidney stones called the SURE procedure for stone evacuation to the standard treatment using a basket for stone removal.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Stone Renal Stone Urolithiasis | Device: SURE Device: Standard Ureteroscopy (Basketing) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 162 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Randomized Study to Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation(SURE)Using the CVAC™ Aspiration System Compared to Basketing for the Removal of Renal Calculi Following Laser Lithotripsy |
| Actual Study Start Date : | June 16, 2021 |
| Estimated Primary Completion Date : | April 2025 |
| Estimated Study Completion Date : | April 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Kidney stones
MedlinePlus related topics:
Kidney Stones
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: SURE |
Device: SURE
The SURE stone evacuation procedure is a technique intended to more easily and completely remove a kidney stone during a kidney stone treatment. The urologist first uses a laser to break the kidney stone into small pieces. Then with the SURE procedure, the pieces are gently vacuumed out of the kidney instead of retrieving the pieces one-by-one with a basket or leaving them to pass naturally in the urine. Basketing is allowed and might be used with the SURE procedure, if needed to remove some small stones. |
| Active Comparator: Standard Ureteroscopy (Basketing) |
Device: Standard Ureteroscopy (Basketing)
This is a treatment in which the urologist uses a laser to break a kidney stone into small pieces and then uses a tool called a basket to retrieve the pieces one at a time. |
Primary Outcome Measures :
- SFR [ Time Frame: 30 days ]Stone Free Rate
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Candidate for ureteroscopy with laser lithotripsy;
- Presence of renal stone(s);
- Be willing and able to return for all study-related follow up procedures; and,
- Have been informed of the nature of the study, agreeing to its requirements, and have signed the IRB approved informed consent.
Exclusion Criteria:
- BMI > 45;
- Significant comorbidities;
- Bladder, ureteral or kidney abnormalities;
- Pregnant individuals; or
- Unable to meet the treatment and follow up protocol requirements.
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): NCT04519294
Locations
| United States, Arizona | |
| Mayo Clinic | |
| Phoenix, Arizona, United States, 85054 | |
| Arizona Institute of Urology | |
| Tucson, Arizona, United States, 85704 | |
| United States, Maryland | |
| Johns Hopkins | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New Jersey | |
| New Jersey Urology | |
| Voorhees, New Jersey, United States, 08043 | |
| United States, New York | |
| Albany Medical College | |
| Albany, New York, United States, 12208 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, South Carolina | |
| Prisma Health | |
| Greenville, South Carolina, United States, 29650 | |
| United States, Texas | |
| Urology Austin | |
| Austin, Texas, United States, 78654 | |
| Dell Medical School, The University of Texas at Austin | |
| Austin, Texas, United States, 78712 | |
| UT Southwestern Medical Center | |
| Dallas, Texas, United States, 75390 | |
| United States, Virginia | |
| Urology of Virginia | |
| Virginia Beach, Virginia, United States, 23462 | |
Sponsors and Collaborators
Calyxo, Inc.
| Responsible Party: | Calyxo, Inc. |
| ClinicalTrials.gov Identifier: | NCT04519294 |
| Other Study ID Numbers: |
CP00001 |
| First Posted: | August 19, 2020 Key Record Dates |
| Last Update Posted: | March 6, 2023 |
| Last Verified: | March 2023 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Product Manufactured in and Exported from the U.S.: | Yes |
Additional relevant MeSH terms:
|
Kidney Calculi Urolithiasis Calculi Pathological Conditions, Anatomical Nephrolithiasis Kidney Diseases |
Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Urinary Calculi Male Urogenital Diseases |