Directly Integrated Suction and Optics System for Kidney Stones
(DISON I Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new device used in retrograde intrarenal surgery (RIRS with Investigational Device) for kidney stones. The goal is to assess the device's safety and effectiveness in removing kidney stones. The trial seeks participants with kidney stones between 0.5 cm and 2.0 cm in size, confirmed by a recent CT scan. Individuals who frequently experience kidney stone issues and meet these criteria might be suitable candidates. As an unphased trial, this study offers a chance to contribute to innovative research that could enhance kidney stone treatment options.
What prior data suggests that this device is safe for use during retrograde intrarenal surgery?
Research has shown that retrograde intrarenal surgery (RIRS) is generally a safe and effective treatment for kidney stones. One study found a low complication rate of only 1.5%, with just one reported case of infection, indicating that complications are rare. Another study highlighted that RIRS is effective even for large stones and is both safe and successful. Additionally, research indicates that RIRS can be safely performed with local anesthesia. Overall, these findings suggest that RIRS is well-tolerated and carries a low risk of serious side effects.12345
Why are researchers excited about this trial?
The investigational endourological device used during retrograde intrarenal surgery (RIRS) for kidney stones is unique because it directly integrates suction and optics into the procedure. This integration allows for more precise and efficient removal of kidney stones compared to traditional methods. Researchers are excited about this treatment because it could potentially reduce surgery time and improve patient outcomes by minimizing the risk of stone fragments being left behind, which are common issues with conventional treatments like shock wave lithotripsy and traditional RIRS.
What evidence suggests that this device is effective for kidney stones?
Research has shown that using a suction technique in retrograde intrarenal surgery (RIRS) is highly effective. One study found that this method successfully broke kidney stones 94% of the time and completely cleared them 89% of the time in patients with stones between 5 and 15 mm. Another study demonstrated that RIRS with suction works well for stones up to 1.5 cm, achieving high rates of stone removal. In this trial, the investigational endourological device will be used during RIRS to enhance these successes by using suction to improve kidney stone removal during surgery. Overall, this approach has yielded promising results in safely and effectively treating kidney stones.678910
Are You a Good Fit for This Trial?
This trial is for people with kidney stones who are scheduled to have retrograde intrarenal surgery (RIRS). Participants should be able to safely undergo this procedure and meet the study's health requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo retrograde intrarenal surgery using the investigational device for the treatment of renal calculi
Follow-up
Participants are monitored for safety and effectiveness, including assessment of stone-free status and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- RIRS with Investigational Device
Trial Overview
The study is testing a new device that combines suction and optics during RIRS, a minimally invasive surgery for removing kidney stones. All participants will receive treatment using this investigational device.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ventaris Surgical Incorporated
Lead Sponsor
Citations
Comparison of suction technique and non-suction ... - PMC
Implementation of the vacuum suction sheath technique in RIRS has proven to be highly effective in addressing upper urinary tract calculi.
Study Details | NCT07712861 | DISON I Directly Integrated ...
A single-arm, multicenter, international, prospective interventional study designed to evaluate the safety and performance of an investigational ...
Retrograde intrarenal surgery: Past, present, and future
initially attained a 94% technical success rate for stone disintegration and a complete stone clearance rate of 89% among 18 patients with 5- to 15-mm renal ...
DISON I Directly Integrated Suction and… | Clinical Trial
Investigational endourological device used during retrograde intrarenal surgery. Primary outcomes. Procedure success. Time frame: Intraoperative.
Comparison Between RIRS and Mini-PCNL in the ...
Both RIRS and mini-PCNL are safe and effective for the management of KS ≥ 15 mm. Mini-PCNL achieves higher SFR and greater cost-efficiency than RIRS.
Retrograde intrarenal surgery for renal stones - Part 2 - PMC
For the stones ranging between 7–30 mm, they reported a SFR of 83% after first session, and 92.3% after the second session. RIRS was an efficient and reliable ...
Safety and Efficacy of Fluoroscopy-free Technique During ...
fluoroscopy-free RIRS is a feasible, effective -free technique can deal with large stones and complex situations with high safety and success rate.
outcomes and Safety of Retrograde Intra-Renal Surgery for ...
The overall SFR for renal stones treated with RIRS in our center was 55.4%, and the complication rate was 1.5%, which consisted of one case of sepsis. The only ...
Indications, Efficacy, Safety and Complications of ...
Gokcen reported that the RIRS method could be used as an effective and safe treatment for kidney stones in patients over the age of 65, with hospitalization and ...
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ctv.veeva.com
ctv.veeva.com/study/analysis-of-the-effectiveness-and-safety-of-retrograde-intrarenal-surgery-rirs-under-local-anestheAnalysis of the Effectiveness and Safety of RIRS Under Local ...
In recent years, more and more studies have shown that retrograde intrarenal surgery (RIRS) under local anesthesia is safe and feasible.
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