Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

NCT03040466 | Completed Results DMC FDA Device

• 1 other identifier: 16-20844
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital. Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Conditions

Kidney Calculi; Ureter Calculi

Keywords

ureteroscopy; flexible ureteroscope; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Overall Procedure Time

  at the surgery day, this will be a duration that each ureteroscopy is performed for a patient, assessed between 10 and 120 minutes

Secondary Outcomes (2)

• Number of Participants That Are Stone Free

  three month after surgery

• Number of Participants With Complications

  from during the surgery to three months after the surgery

Study Arms (2)

reusable fiberoptic ureteroscope

ACTIVE COMPARATOR

For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using reusable fiberoptic flexible ureteroscope (URF-P6, Olympus). The surgical method of the ureteroscopy will be a standard fashion same as other arms.

Device: reusable fiberoptic ureteroscope

disposable digital ureteroscope

EXPERIMENTAL

For this arm, participants will receive the ureteroscopy for their kidney and ureter stones using disposable digital flexible ureteroscope (LithoVue, Boston Scientific). The surgical method of the ureteroscopy will be a standard fashion same as other arms.

Device: disposable digital ureteroscope

Interventions

reusable fiberoptic ureteroscope DEVICE

We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.

reusable fiberoptic ureteroscope

disposable digital ureteroscope DEVICE

We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.

disposable digital ureteroscope

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥ 18 years of age at their first clinical visit.
• Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
• Patients being able and willing to provide consent.

You may not qualify if:

• Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
• Pregnancy.
• Staged ureteroscopic procedure.
• Antegrade flexible ureteroscopy.
• Dual procedures (ureteroscopy concurrently performed with other operations).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (12)

• Healy KA, Pak RW, Cleary RC, Colon-Herdman A, Bagley DH. Hand problems among endourologists. J Endourol. 2011 Dec;25(12):1915-20. doi: 10.1089/end.2011.0128. Epub 2011 Oct 17.

  PMID: 22004843 BACKGROUND

• Karaolides T, Bach C, Kachrilas S, Goyal A, Masood J, Buchholz N. Improving the durability of digital flexible ureteroscopes. Urology. 2013 Apr;81(4):717-22. doi: 10.1016/j.urology.2013.01.016. Epub 2013 Mar 7.

  PMID: 23465156 BACKGROUND

• Multescu R, Geavlete B, Geavlete P. A new era: performance and limitations of the latest models of flexible ureteroscopes. Urology. 2013 Dec;82(6):1236-9. doi: 10.1016/j.urology.2013.07.022. Epub 2013 Aug 28.

  PMID: 23992972 BACKGROUND

• Somani BK, Al-Qahtani SM, de Medina SD, Traxer O. Outcomes of flexible ureterorenoscopy and laser fragmentation for renal stones: comparison between digital and conventional ureteroscope. Urology. 2013 Nov;82(5):1017-9. doi: 10.1016/j.urology.2013.07.017. Epub 2013 Aug 31.

  PMID: 24001703 BACKGROUND

• Carey RI, Martin CJ, Knego JR. Prospective evaluation of refurbished flexible ureteroscope durability seen in a large public tertiary care center with multiple surgeons. Urology. 2014 Jul;84(1):42-5. doi: 10.1016/j.urology.2014.01.022. Epub 2014 May 14.

  PMID: 24837456 BACKGROUND

• de la Rosette J, Denstedt J, Geavlete P, Keeley F, Matsuda T, Pearle M, Preminger G, Traxer O; CROES URS Study Group. The clinical research office of the endourological society ureteroscopy global study: indications, complications, and outcomes in 11,885 patients. J Endourol. 2014 Feb;28(2):131-9. doi: 10.1089/end.2013.0436. Epub 2013 Dec 17.

  PMID: 24147820 BACKGROUND

• Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.

  PMID: 24890883 BACKGROUND

• Tosoian JJ, Ludwig W, Sopko N, Mullins JK, Matlaga BR. The effect of repair costs on the profitability of a ureteroscopy program. J Endourol. 2015 Apr;29(4):406-9. doi: 10.1089/end.2014.0435. Epub 2014 Nov 7.

  PMID: 25286008 BACKGROUND

• Buttice S, Sener TE, Netsch C, Emiliani E, Pappalardo R, Magno C. LithoVue: A new single-use digital flexible ureteroscope. Cent European J Urol. 2016;69(3):302-305. doi: 10.5173/ceju.2016.872. Epub 2016 Aug 26. No abstract available.

  PMID: 27730000 BACKGROUND

• Doizi S, Kamphuis G, Giusti G, Andreassen KH, Knoll T, Osther PJ, Scoffone C, Perez-Fentes D, Proietti S, Wiseman O, de la Rosette J, Traxer O. First clinical evaluation of a new single-use flexible ureteroscope (LithoVue): a European prospective multicentric feasibility study. World J Urol. 2017 May;35(5):809-818. doi: 10.1007/s00345-016-1936-x. Epub 2016 Sep 26.

  PMID: 27671898 BACKGROUND

• Martin CJ, McAdams SB, Abdul-Muhsin H, Lim VM, Nunez-Nateras R, Tyson MD, Humphreys MR. The Economic Implications of a Reusable Flexible Digital Ureteroscope: A Cost-Benefit Analysis. J Urol. 2017 Mar;197(3 Pt 1):730-735. doi: 10.1016/j.juro.2016.09.085. Epub 2016 Sep 28.

  PMID: 27693449 BACKGROUND

• Usawachintachit M, Isaacson DS, Taguchi K, Tzou DT, Hsi RS, Sherer BA, Stoller ML, Chi T. A Prospective Case-Control Study Comparing LithoVue, a Single-Use, Flexible Disposable Ureteroscope, with Flexible, Reusable Fiber-Optic Ureteroscopes. J Endourol. 2017 May;31(5):468-475. doi: 10.1089/end.2017.0027. Epub 2017 Mar 13.

  PMID: 28287823 RESULT

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Thomas Chi
• Organization: UCSF

tom.chi@ucsf.edu;manint.usawachintachit@ucsf.edu

415-476-1611

Study Officials

• Thomas Chi, MD

  Urology, University of California San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be assigned to each 3 type of ureteroscope and receive the flexible ureteroscopy. In each ureteroscopy, only one type of ureteroscope will be used; therefore this study will be parallel model.

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: February 2, 2017
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)