search
Back to results

Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery

Primary Purpose

Kidney Stone

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tip bendable suction ureteral access sheath
Sponsored by
The First Affiliated Hospital of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Stone focused on measuring Kidney stone, Flexible ureteroscopy, Ureteral access sheath

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adults aged ≥ 18 years; American Society of Anesthesiology score 1-2; Kidney stone diameter of ≤ 3 cm confirmed by CT; Capable of giving written informed consent, which includes adherence with the requirements of the trial. Exclusion Criteria: Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit); Patients with uncontrolled UTI; Patients with health or other factors that are absolute contraindications to RIRS; Patients unable to understand or complete trial documentation.

Sites / Locations

  • Department of Urology, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tip bendable suction ureteral access sheath (S-UAS) group

Traditional ureteral access sheath group

Arm Description

Patients will use S-UAS during flexible ureteroscopy.

Patients will use traditional UAS during flexible ureteroscopy.

Outcomes

Primary Outcome Measures

Immediate stone-free rate
No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.

Secondary Outcome Measures

Stone-free rate at 3 months
Duration of hospital stay
Further interventions received up to 3 months post randomization
Complications up to 3 months post randomization
Change of Quality of life Score (prior to surgery and at month 3 after randomization)
Patient costs during hospitalization and up to 3 months

Full Information

First Posted
June 17, 2023
Last Updated
July 17, 2023
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xinchang Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Xiangya Hospital, Prof. Dr. Ilhan Varank Education and Training Hospital, San Bassiano Hospital, Mt. Carmel Diocesan General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05952635
Brief Title
Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery
Official Title
Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xinchang Hospital of Traditional Chinese Medicine, Jiangxi Provincial People's Hopital, Xiangya Hospital, Prof. Dr. Ilhan Varank Education and Training Hospital, San Bassiano Hospital, Mt. Carmel Diocesan General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications. The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend >90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone
Keywords
Kidney stone, Flexible ureteroscopy, Ureteral access sheath

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tip bendable suction ureteral access sheath (S-UAS) group
Arm Type
Experimental
Arm Description
Patients will use S-UAS during flexible ureteroscopy.
Arm Title
Traditional ureteral access sheath group
Arm Type
No Intervention
Arm Description
Patients will use traditional UAS during flexible ureteroscopy.
Intervention Type
Procedure
Intervention Name(s)
Tip bendable suction ureteral access sheath
Intervention Description
Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications.
Primary Outcome Measure Information:
Title
Immediate stone-free rate
Description
No residual stone or stone fragments less than 2 mm on low-dose CT scan at postoperative day 1 are defined as stone free.
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Stone-free rate at 3 months
Time Frame
Postoperative 3 month
Title
Duration of hospital stay
Time Frame
From date of operation until the date of discharge, assessed up to 2 weeks.
Title
Further interventions received up to 3 months post randomization
Time Frame
Postoperative 3 month
Title
Complications up to 3 months post randomization
Time Frame
Postoperative 3 month
Title
Change of Quality of life Score (prior to surgery and at month 3 after randomization)
Time Frame
Postoperative 3 month
Title
Patient costs during hospitalization and up to 3 months
Time Frame
Postoperative 3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults aged ≥ 18 years; American Society of Anesthesiology score 1-2; Kidney stone diameter of ≤ 3 cm confirmed by CT; Capable of giving written informed consent, which includes adherence with the requirements of the trial. Exclusion Criteria: Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit); Patients with uncontrolled UTI; Patients with health or other factors that are absolute contraindications to RIRS; Patients unable to understand or complete trial documentation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, M.D.
Phone
0086-020-34294145
Email
gzgyzgh@vip.sina.com
Facility Information:
Facility Name
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, M.D.
Phone
+8613802916676
Email
gzgyzgh@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Wei Zhu, M.D.
Email
doczw1989@126.com
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, M.D.
First Name & Middle Initial & Last Name & Degree
Wei Zhu, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery

We'll reach out to this number within 24 hrs