Recruiting

Reverse Trendelenburg vs. T-Tilt

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07601932

Conditions

Ureteral Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Reverse Trendelenburg Position

T-Tilt Position

Study Details

Brief summary:

Ureteroscopic management of proximal ureteral stones presents technical challenges including stone retropulsion, prolonged operative time, and conversion to intrarenal treatment. Reverse Trendelenburg positioning has been shown to reduce proximal stone migration and operative time in ureteral stones, while the T-tilt position improves intrarenal stone clearance. The optimal strategy for proximal ureteral stones (treating stones in situ using reverse Trendelenburg versus pushing stones into the kidney followed by intrarenal treatment in T-tilt) remains unknown.

This randomized controlled trial compares these two strategies, with primary focus on operative time as a measure of procedural efficiency.

A total of 54 patients (27 per arm) will be enrolled at Mount Sinai West.

Conditions

Ureteral Stone

Study ID

NCT07601932

Start date

May 21, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • Adults aged 18 years and older.
  • Diagnosed with kidney stones and scheduled for fURS.
  • Stone burden > 1 cm and/or multiple stones will be eligible.
  • Able and willing to provide informed consent.

Exclusion criteria:

  • Pregnant persons as determined by pre-operative urine pregnancy test (standard of care at the institution)
  • Untreated UTI
  • Patients with urinary anomalies (e.g., urinary diversion, ureteral reconstruction, horseshoe kidney)
  • Single stone < 1 cm

Study Design

Enrollment

54 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Reverse Trendelenburg Position

Participants undergo ureteroscopic lithotripsy in reverse Trendelenburg positioning with attempted in situ treatment of the proximal ureteral stone to minimize proximal migration.

active comparator: T-Tilt Position

Participants undergo intentional relocation of the proximal ureteral stone into the kidney followed by intrarenal lithotripsy performed in the T-tilt position.

Interventions

Reverse Trendelenburg Position

Patients will be positioned in reverse Trendelenburg at a 20 degree incline with the use of a digital protractor. Lithotripsy will be performed within the ureter with attempts to prevent proximal migration and until all fragments are removed.

T-Tilt Position

Stone will be intentionally relocated into the kidney when feasible, followed by intrarenal lithotripsy in T-tilt position. In the T-tilt position the table is angled 15-degree Trendelenburg and 15-degree airplane away from the surgical side kidney with the use of a digital protractor. This allows fragments to rest in a superior and medial position away from the lower pole to facilitate removal.

Primary outcome measure

  • Total operative time [ Time Frame: Immediately postoperatively on the day of surgery ]

Central Contacts and Locations

Central contacts

Mantu Gupta, MD

212-241-1272mantu.gupta@mountsinai.org

Blair Gallante, MPH

212-241-1272blair.gallante@mountsinai.org

Locations

Mount Sinai West

Recruiting

New York, New York, United States, 10019

Contacts

Mantu Gupta, MD

212-241-1272Mantu.gupta@mountsinai.org

Blair Gallante, MPH

212-241-1272blair.gallante@mountsinai.org

Principal Investigator:

Mantu Gupta, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-06-04.