Last reviewed · How we verify
NCT04009746: Spyglass
Italian Registry of ERCP With Spyglass
trial testing Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass in Biliary Condition in 150 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 21 January 2016 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass
Conditions studied
- Biliary Condition — all drugs for Biliary Condition →
Sponsor
Istituto Clinico Humanitas
Who can join
18 and older, female only, with Biliary Condition. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts. The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope. Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones. The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04009746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Istituto Clinico Humanitas trials
Trials by the same sponsor.
- NCT06944288 — Microbiota as Early Diagnostic and predictivE Factor for Osteoarthritic Degeneration and Microbial Contamination · NA · not yet recruiting
- NCT07358247 — Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction · not yet recruiting
- NCT07362342 — RIght VEntricle Response to Major Lung Resection in VATS and Robotic Surgery · not yet recruiting
- NCT07346274 — Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. · enrolling by invitation
- NCT07491419 — The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04009746 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 21 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04009746.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing