- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07559214
FANS VS DISS in Treatment of Renal Stone < 2cm
23. april 2026 oppdatert av: Armia Ezzat Thabet Azer, Assiut University
Flexible and Navigable Access Sheath (FANS) VS Direct in Scope Suction (DISS) in Treatment of Renal Stone > 2 cm , Controlled Randomized Trial
To compare between FANS & DISS in :
- Operative time
- Stone free rate
- Complications
- Amount of fluid irrigation
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Retrograde intrarenal surgery (RIRS) has revolutionized the management of renal stones, yet achieving high stone-free rates (SFR) while maintaining low intrarenal pressure (IRP) remains a challenge.
Elevated IRP during irrigation is linked to post-operative complications, including systemic inflammatory response syndrome and renal parenchymal damage.
To mitigate these risks, suction-assisted technologies have emerged as vital adjuncts to traditional flexible ureteroscopy (FURS).The Flexible and Navigable Access Sheath (FANS) represents a significant evolution in this field.
Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation.
Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope.
While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency.For renal stones measuring less than 2 cm, both techniques aim to optimize the "perfusion-absorption" balance, effectively clearing stone dust and debris while preventing pyelovenous reflux.
However, comparative data specifically for smaller stones remains limited.
This study evaluates the clinical efficacy, safety profiles, and operative outcomes of FANS versus DISS in the treatment of renal calculi < 2 cm, aiming to determine which suction modality provides the most favorable balance of procedural efficiency and patient safety.
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- All patients < 18 years old presented with renal stone > 2cm whatever the site of the stone (pelvic or calyceal)
Exclusion Criteria:
- Inaccessibility to introduce access sheath or FURS
- Previous Inserted JJ stent
- Active UTI
- Patients refuse to participate in the protocol
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Flexible and navigable access sheath (FANS)
In patients undergoing the FANS procedure , an access sheath with a bendable tip and aspiration feature will be placed into the relevant ureter up to the renal pelvis over the guidewire.
The single-use flexible scope will be passed through the access sheath, and the renal collecting system.
After this maneuver, the tip of the placed access sheath will be pushed into the renal calyces or pelvis under the guidance of the flexible URS and a holmium fiber will be used to pulverize the stones with a 273-µm fiber.
In this group, stones were disintegrated (fragmented) into an adequate size (< 3 mm) to allow an efficient extraction with the help of active aspiration, finished by insertion of JJ in all patients.
|
Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation.
Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope.
While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency
Andre navn:
|
|
Eksperimentell: Direct in scope suction (DISS)
In the DISS group, a single-use flexible URS with a direct in-scope suction system will be introduced over the placed guidewire and navigated into the renal pelvis without the use of an access sheath.
The suctioning port on the ureteroscope and the laser fiber operates via the same port.
In this group, the dusting preset of the same laser device will be used to disintegrate the stones.
While continuous irrigation was applied to ensure optimum visualization, finished by insertion of JJ in all patients
|
Unlike traditional rigid sheaths, FANS features a deflectable tip that can be guided into specific calyces, allowing for synchronized suction and active fragment evacuation.
Conversely, Direct In-Scope Suction (DISS) utilizes a sheathless approach, where suction is integrated directly into the ureteroscope.
While DISS avoids potential ureteral trauma associated with access sheaths, FANS is often associated with shorter operative times due to its superior irrigation-aspiration efficiency
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Operative time
Tidsramme: <60 minutes
|
The operative time is the duration of surgical procedure
|
<60 minutes
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
1. juni 2027
Studiet fullført (Antatt)
1. september 2027
Datoer for studieregistrering
Først innsendt
10. april 2026
Først innsendt som oppfylte QC-kriteriene
23. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. april 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. april 2026
Sist bekreftet
1. april 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Urogenitale sykdommer
- Mannlige urogenitale sykdommer
- Calculi
- Patologiske tilstander, anatomiske
- Nyresykdommer
- Urologiske sykdommer
- Kvinnelige urogenitale sykdommer
- Kvinnelige urogenitale sykdommer og graviditetskomplikasjoner
- Urolithiasis
- Urinkalkuli
- Nefrolitiasis
- Patologiske tilstander, tegn og symptomer
- Nyreberegning
Andre studie-ID-numre
- FANS VS DISS
Legemiddel- og utstyrsinformasjon, studiedokumenter
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