Flexible Ureterorenoscopy for Surveillance of Upper Tract... | NCT07557563

Studies
Flexible Ureterorenoscopy for Surveillance of Upper Tract Urothelial Carcinoma

NCT07557563

Sponsor

Chinese University of Hong Kong

Status

Not yet recruiting

Last Update Posted

May 5, 2026Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Upper Tract Urothelial Carcinoma

Interventions

Flexible ureterorenoscopy

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Mar 31, 2028Estimated

First Submitted Date

Apr 22, 2026

First Submission Date that Met QC Criteria

Apr 22, 2026

First Posted Date

Apr 29, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2026

Last Update Posted Date

May 5, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeremy Yuen Chun TEOH, Associate Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It is a prospective single-arm pilot study to investigate the safety and feasibility of flexible ureteroscopy under local anaesthesia.

Detailed Description

All consecutive patients who have undergone kidney-sparing surgery for managing upper tract urothelial carcinoma will be screened for study eligibility. Surveillance flexible ureteroscopy of the upper urinary tract under local anaesthesia in an ambulatory care setting. The peri-operative outcomes, patient reported outcomes, complication and cost-effectiveness analysis will be evaluated.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Arm	Experimental	Flexible ureterorenoscopy for Surveillance of UTUC under local anaesthesia	Other: Flexible ureterorenoscopy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flexible ureterorenoscopy	Other	Flexible ureterorenoscopy for Surveillance of UTUC under local anaesthesia	Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedure success rate	The procedure is completed successfully.	Immediately postoperatively

Secondary Outcomes

Measure	Description	Time Frame
Complication rate	Assessed by Clavien Dindo Classification	On day 30
Readmission rate	Assessed by readmission to hospital after discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 years or older
Capable of giving informed consent
Having undergone an kidney-sparing surgery (endoscopic operation or segmental ureterectomy)

Exclusion Criteria:

Allergy to transurethral lidocaine jelly
On anticoagulation or anti-platelet medication with contraindications for cessation prior to the procedure
Structural abnormalities in the upper urinary tract on the intended side of examination

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ho Ming Chris WONG, MBChB	Contact	35052625		chriswong@surgery.cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Yuen Chun Jeremy TEOH, MD	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital		Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided