Storz Professional Image Enhancement System Versus White Light Imaging Assisted TURBT for Treatment of NMIBC

NCT03138824 | Unknown DMC

• 1 other identifier: MS/17.03.57
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Compare the therapeutic utility of SPIES assisted TURB with WLI assisted TURB in patients with non-muscle invasive bladder cancer.

Conditions

Bladder Urothelial Carcinoma; TURBT; Bladder Neoplasm; Cystoscopy

Keywords

Bladder Urothelial Carcinoma; TURBT; Recurrence; Progression

Outcome Measures

Primary Outcomes (1)

• Tumor recurrence after TURBT in patients with NMIBC

  inpatient cystoscopy of the tumor site for detection of tumor recurrence disease in each arm

  3 months after primary procedure

Secondary Outcomes (1)

• 1-year recurrence free survival

  1 year

Study Arms (2)

SPIES assisted TURBT

EXPERIMENTAL

Storz Professional Image Enhancement System (SPIES) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer

Procedure: SPIES assisted TURBT

WLI assisted TURBT

EXPERIMENTAL

White Light Imaging (WLI) assisted transurethral resection of bladder tumour for Non-muscle invasive bladder cancer

Procedure: WLI assisted TURBT

Interventions

SPIES assisted TURBT PROCEDURE

SPIES assisted TURBT of NMIBC

Also known as: Storz Professional Image Enhancement System (SPIES)

SPIES assisted TURBT

WLI assisted TURBT PROCEDURE

White Light Imaging (WLI) assisted TURBT for treatment of NMIBC

Also known as: White Light Imaging (WLI)

WLI assisted TURBT

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed at the out-patient cystoscopy with papillary bladder or small resectable lesion that can be resected tumour

You may not qualify if:

• Tumor criteria
• a. Beyond scope of resection
• Patients criteria
• Poor performance status
• History of bladder irradiation
• Contracted bladder

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Aldakahlia, 35516, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Recurrence; Disease Progression

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Mosbah, MD, Phd

  Urology and Nephrology Center

  STUDY CHAIR

• Bedir Ali-Eldeen, MD, Phd

  Urology and Nephrology Center

  STUDY DIRECTOR

• Ahmed Elshal, MD

  Urology and Nephrology Center

  STUDY DIRECTOR

• Abdelwahab Hashem, Msc

  Urology and Nephrology center

  PRINCIPAL INVESTIGATOR

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: PRINCIPAL INVESTIGATOR
• PI Title: Msc

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 15, 2017
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 23, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)