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Recruiting NCT06438497

NCT06438497 The Effect of Different Body Positions and Channel Sheaths on RIRS

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Clinical Trial Summary
NCT ID NCT06438497
Status Recruiting
Phase
Sponsor The First Affiliated Hospital of Guangzhou Medical University
Condition Urolithiasis
Study Type INTERVENTIONAL
Enrollment 120 participants
Start Date 2024-05-23
Primary Completion 2024-11

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 70 Years
Study Type INTERVENTIONAL
Interventions
RIRS with f-UAS, lateral positionRIRS with f-UAS, lithotomy positionRIRS with traditional UAS, lateral position

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 120 participants in total. It began in 2024-05-23 with a primary completion date of 2024-11.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

Retrograde flexible ureteroscopy (RIRS) is currently the first-line treatment for renal stones \< 2cm. Lower pole renal stones(LPS) are a difficult problem for urologists. The flexible negative pressure suction ureteral sheath(f-UAS) can facilitate RIRS to flush out the fragments and dust in time, and provide a clear vision and reduce the renal pelvis pressure(RPP) during operation.Standard lithotomy position is the most commonly used position for RIRS. Besides, T-tilt position is also available for RIRS in special cases. Investigators were inspired by this and proposed the lateral position, which is available in cases of LPS.In long-term practice, investigators have found that the change of position and the use of f-UAS can improve stone-free rate(SFR). Investigators aimed to conduct a prospective randomized controlled trial to compare the SFR of different positions and different ureteral sheaths.

Eligibility Criteria

Inclusion Criteria: * LPS with a diameter of 10-20 mm * American Society of Anesthesiologists(ASA) score Ⅰ,Ⅱ and Ⅲ * Adult patients Exclusion Criteria: * Ureteric stricture * Urethral deformity * Renal malformation, including horseshoe kidney, ectopic kidney and transplanted kidney * Pregnancy * Multiple stones in diferent calyces, including upper pole and middle pole

Contact & Investigator

Central Contact

Guohua Zeng, Ph.D and M.D

✉ gzgyzgh@vip.tom.com

📞 +8613802916676

Frequently Asked Questions

Who can join the NCT06438497 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Urolithiasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06438497 currently recruiting?

Yes, NCT06438497 is actively recruiting participants. Contact the research team at gzgyzgh@vip.tom.com for enrollment information.

Where is the NCT06438497 trial being conducted?

This trial is being conducted at Guangzhou, China.

Who is sponsoring the NCT06438497 clinical trial?

NCT06438497 is sponsored by The First Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 120 participants.

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