---
title: Laser Lithotripsy During URS - Holmium vs Thulium
nct_id: NCT04668586
overall_status: COMPLETED
phase: NA
sponsor: Haukeland University Hospital
study_type: INTERVENTIONAL
primary_condition: Urolithiasis
countries: Norway
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04668586.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04668586"
ct_last_update_post_date: 2025-03-30
last_seen_at: "2026-05-12T06:18:40.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Laser Lithotripsy During URS - Holmium vs Thulium

**Official Title:** Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety

**NCT ID:** [NCT04668586](https://clinicaltrials.gov/study/NCT04668586)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Haukeland University Hospital
- **Conditions:** Urolithiasis
- **Start Date:** 2021-01-14
- **Completion Date:** 2021-10-31
- **CT.gov Last Update:** 2025-03-30

## Brief Summary

The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

## Detailed Description

The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.

Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway

Exclusion Criteria:

* Known pathology of the upper urinary tract
* Untreated infection
```

## Arms

- **Holmium:YAG laser machine** (EXPERIMENTAL) — The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
- **Thulium Fiber laser machine** (EXPERIMENTAL) — The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.

## Interventions

- **Holmium:YAG laser machine** (DEVICE) — Ureteroscopy with Holmium:YAG laser lithotripsy
- **Thulium Fiber laser machine** (DEVICE) — Ureteroscopy with Thulium Fiber laser lithotripsy

## Primary Outcomes

- **Stone Free Rate** _(time frame: 3 months after the URS)_ — Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.

## Secondary Outcomes

- **Operating Time** _(time frame: Decided immediately after the surgery)_
- **Intraoperative Complications** _(time frame: Decided immediately after the surgery)_
- **Postoperative Complications** _(time frame: Within 3 months post endoscopically)_
- **Postoperative JJ-stenting** _(time frame: Decided immediately after the surgery)_

## Locations (1)

- Haukeland University Hospital, Bergen, Vestland, Norway

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.haukeland university hospital|bergen|vestland|norway` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04668586.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04668586*  
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