NCT02426931

Brief Summary

This study evaluates the safety and efficacy of the novel tip-flexible semi-rigid ureterorenoscope for the treatment of renal calculi using a prospective, randomized multicentre trial design. Half of participants will receive retrograde intrarenal surgery using the tip-flexible semi-rigid ureterorenoscope, while the other half participants will receive retrograde intrarenal surgery using the classic flexible ureteroscope.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

2 months

First QC Date

February 12, 2015

Last Update Submit

April 22, 2015

Conditions

Renal Calculi

Keywords

retrograde intrarenal surgeryflexible ureteroscopyrenal calculi

Outcome Measures

Primary Outcomes (1)

  • Stone clearance

    Number of participants undergo tf-URS or f-URS surgeries without residual calculus/Total number of participants in each group \*100%

    12 weeks post-operatively

Secondary Outcomes (5)

  • Stone clearance

    One day post-operatively

  • Complication rates

    Within 12 weeks after surgery

  • Endoscope deflection loss rates

    intraoperative

  • Endoscope Leakage rates

    intraoperative

  • Endoscope black dots rates

    intraoperative

Study Arms (2)

tf-URS

EXPERIMENTAL

Participants in tf-URS group undergo ureteroscopy using the tip-flexible ureterorenoscope.

Device: the tip-flexible ureterorenoscope

f-URS

ACTIVE COMPARATOR

Participants in f-URS group undergo ureteroscopy using the classic flexible ureteroscope.

Device: the classic flexible ureteroscope

Interventions

the tip-flexible ureterorenoscopeDEVICE

Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.

tf-URS
the classic flexible ureteroscopeDEVICE

Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.

f-URS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject has provided informed consent and indicated a willingness to comply with study treatments
  • Subject has a diagnosis of renal stones according to computer tomography (CT) and intravenous pyelogram (IVP) results
  • Subject is a surgical candidate for the ureteroscopic approach
  • Subject is 18-80 yrs of age
  • Subject has a single stone \< 3 cm in size (IVP), or multiple stones \< 3 cm in cumulative size (IVP)
  • Subject has a serum creatinine level within the normal range for the study center

You may not qualify if:

  • Subject needs bilateral procedures within one-stage ureteroscopy
  • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
  • Subject has been diagnosed with a urethral stricture or bladder neck contracture
  • Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
  • Subject has severe hematuria that might blur the vision of the endoscopy
  • Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
  • Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 d)
  • Subject has other diseases and could not tolerate the endoscopic surgery
  • Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
  • Subject has ipsilateral pre-stenting or previous ureteroscopy within six months
  • Subject has been diagnosed with hydronephrosis larger than 3 cm according to the B-scan ultrasonography examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (16)

  • Aboumarzouk OM, Monga M, Kata SG, Traxer O, Somani BK. Flexible ureteroscopy and laser lithotripsy for stones >2 cm: a systematic review and meta-analysis. J Endourol. 2012 Oct;26(10):1257-63. doi: 10.1089/end.2012.0217. Epub 2012 Jul 30.

    PMID: 22642568BACKGROUND

  • 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: 24147820BACKGROUND

  • 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: 24890883BACKGROUND

  • Yoon PD, Chalasani V, Woo HH. Use of Clavien-Dindo classification in reporting and grading complications after urological surgical procedures: analysis of 2010 to 2012. J Urol. 2013 Oct;190(4):1271-4. doi: 10.1016/j.juro.2013.04.025. Epub 2013 Apr 11.

    PMID: 23583859BACKGROUND

  • Yinghao S, Yang B, Gao X. The management of renal caliceal calculi with a newly designed ureteroscope: a rigid ureteroscope with a deflectable tip. J Endourol. 2010 Jan;24(1):23-6. doi: 10.1089/end.2009.0030.

    PMID: 20059383BACKGROUND

  • Rebuck DA, Macejko A, Bhalani V, Ramos P, Nadler RB. The natural history of renal stone fragments following ureteroscopy. Urology. 2011 Mar;77(3):564-8. doi: 10.1016/j.urology.2010.06.056. Epub 2010 Dec 15.

    PMID: 21109293BACKGROUND

  • Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8.

    PMID: 22982421BACKGROUND

  • Atis G, Arikan O, Gurbuz C, Yildirim A, Erol B, Pelit S, Ulus I, Caskurlu T. Comparison of different ureteroscope sizes in treating ureteral calculi in adult patients. Urology. 2013 Dec;82(6):1231-5. doi: 10.1016/j.urology.2013.07.021. Epub 2013 Sep 12.

    PMID: 24035032BACKGROUND

  • Perez Castro E, Osther PJ, Jinga V, Razvi H, Stravodimos KG, Parikh K, Kural AR, de la Rosette JJ; CROES Ureteroscopy Global Study Group. Differences in ureteroscopic stone treatment and outcomes for distal, mid-, proximal, or multiple ureteral locations: the Clinical Research Office of the Endourological Society ureteroscopy global study. Eur Urol. 2014 Jul;66(1):102-9. doi: 10.1016/j.eururo.2014.01.011. Epub 2014 Jan 23.

    PMID: 24507782BACKGROUND

  • Karadag MA, Demir A, Cecen K, Bagcioglu M, Kocaaslan R, Altunrende F. Flexible ureterorenoscopy versus semirigid ureteroscopy for the treatment of proximal ureteral stones: a retrospective comparative analysis of 124 patients. Urol J. 2014 Nov 1;11(5):1867-72.

    PMID: 25361706BACKGROUND

  • Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.

    PMID: 21052986BACKGROUND

  • Wendt-Nordahl G, Trojan L, Alken P, Michel MS, Knoll T. Ureteroscopy for stone treatment using new 270 degrees semiflexible endoscope: in vitro, ex vivo, and clinical application. J Endourol. 2007 Dec;21(12):1439-44. doi: 10.1089/end.2006.0291.

    PMID: 18186680BACKGROUND

  • Geavlete P, Multescu R, Geavlete B. Retrograde flexible ureteroscopic approach of upper urinary tract pathology: What is the status in 2014? Int J Urol. 2014 Nov;21(11):1076-84. doi: 10.1111/iju.12582. Epub 2014 Aug 1.

    PMID: 25081354BACKGROUND

  • Bedke J, Leichtle U, Lorenz A, Nagele U, Stenzl A, Kruck S. 1.2 French stone retrieval baskets further enhance irrigation flow in flexible ureterorenoscopy. Urolithiasis. 2013 Apr;41(2):153-7. doi: 10.1007/s00240-012-0540-9. Epub 2013 Jan 5.

    PMID: 23503877BACKGROUND

  • 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: 24001703BACKGROUND

  • Ozsoy M, Acar O, Sarica K, Saratlija-Novakovic Z, Fajkovic H, Librenjak D, Esen T, Scheffbuch N, Seitz C. Impact of gender on success and complication rates after ureteroscopy. World J Urol. 2015 Sep;33(9):1297-302. doi: 10.1007/s00345-014-1435-x. Epub 2014 Nov 12.

    PMID: 25385490BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Yinghao Sun, MD

    Changhai Hospital

    STUDY CHAIR

  • Guohua Zeng, MD

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

  • Hequn Chen, MD

    Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

  • Yue Cheng, MD

    Ningbo No. 1 Hospital

    PRINCIPAL INVESTIGATOR

  • Kunjie Wang, MD

    West China Hospital

    PRINCIPAL INVESTIGATOR

  • Jianxing Li, MD

    Beijing Tsinghua Changgeng Hospital

    PRINCIPAL INVESTIGATOR

  • Lei Shi, MD

    Yantai Yuhuangding Hospital

    PRINCIPAL INVESTIGATOR

  • Xiaofeng Gao, MD

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ling Li, MD

CONTACT

086-18019766513ejdll@163.com

Yonghan Peng, MD

CONTACT

086-13917386896yonghanyhtl@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief of Department of Urology

Study Record Dates

First Submitted

February 12, 2015

First Posted

April 27, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 27, 2015

Record last verified: 2015-04