Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography

NCT04561414 | Withdrawn FDA Device

• 1 other identifier: Stryker03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief Summary

This clinical trial is a prospective, multi-center, single-blind, parallel, randomized controlled superiority clinical trial. The trial will be carried out in 5 centers, involving 120 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 60 subjects). This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and candidates are screened; after screening, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device tested; safety follow-up visit is carried out during the follow-up period.

Conditions

Lower Abdominal Surgery; Pelvic Surgery

Keywords

rectal cancer; endometriosis; cervical cancer; adenomyosis; pelvic adhesion

Outcome Measures

Primary Outcomes (1)

• Resolution of the ureter in the whole operation.

  On the operation date, the investigators will score the performance using a scale (1 very good - 10 worst outcome) to evaluate the resolution of the ureter in the whole process of operation.

  in the whole process of operation

Study Arms (2)

LED light source system for endoscope

OTHER

The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use LED light source system for endoscope

Device: LED light source system for endoscope

Ureteral stent (Cook Ireland Ltd.)

OTHER

The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The control group use Ureteral stent (Cook Ireland Ltd.)

Device: Ureteral stent (Cook Ireland Ltd.)

Interventions

LED light source system for endoscope DEVICE

The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use LED light source system for endoscope.

LED light source system for endoscope

Ureteral stent (Cook Ireland Ltd.) DEVICE

The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use Ureteral stent (Cook Ireland Ltd.).

Ureteral stent (Cook Ireland Ltd.)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The surgeon believes preventative placement of a ureteral stent is necessary and the target organ to be excised in the surgery is closely related to the ureter (e.g. representative specialized operations such as rectal cancer and endometriosis, cervical cancer, adenomyosis and pelvic adhesion).
• Age: 18 to 80 years old;
• All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form.

You may not qualify if:

• Women during pregnancy or lactation;
• Subjects are involved in other clinical trials at the same time; Hydronephrosis due to urinary tract obstruction; Laparotomy is expected (except for conversion to laparotomy during operation);
• Other conditions deemed by the investigators as unsuitable for operation;
• Other conditions deemed by the investigators as unsuitable for the trial (including anticipated catheterizing failure).

Sponsors & Collaborators

• Stryker Orthopaedics: lead

Study Sites (4)

Beijing Chao-Yang Hospital,Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100000, China

Location

The First Affiliated Hospital of Jilin University

Jilin, Changchun, 130000, China

Location

Obstetrics&Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Rectal Neoplasms; Endometriosis; Uterine Cervical Neoplasms; Adenomyosis

Interventions

Endoscopes

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Surgical Equipment

Study Officials

• Zhongtao Zhang

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: In this trial, single-blind method will be used, which means that the investigators know about the device used for treatment of the subjects while the subjects know nothing about it.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved.

Study Record Dates

• First Submitted: September 17, 2020
• First Posted: September 23, 2020
• Study Start: May 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 12, 2021

Record last verified: 2021-04

Locations

CN (4)