N/A N=26

Accuracy of Spybite Forceps When Compared to Conventional Sampling Methods

Accuracy of Tissue Diagnosis · Bile Duct Stricture · Pancreatic Duct Stricture

Bottom Line

View on ClinicalTrials.gov: NCT01227382 ↗

Enrolled (actual)

Serious AEs

3.9%

Results posted

Aug 2015

Primary outcome: Primary: Percentage of Participants With Accurate Diagnoses of Cancer — 38.5; 53.9; 84.6 percentage of accurate diagnoses

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ERCP with cholangiopancreatoscopy (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Accurate Diagnoses of Cancer	38.5; 53.9; 84.6	—
SECONDARY Procedure Technical Success	26	—
SECONDARY Total Procedure Time	54.00	—
SECONDARY Total Cholangioscopy Time	23.65	—
SECONDARY Cholangioscopy Visualization Time	11.69	—
SECONDARY Sampling Times for Each Device	11.92; 3.77; 5.73	—
SECONDARY Adverse Events	3	—

Summary

The investigators are evaluating the use of a SpyBite biopsy forceps for tissue diagnosis when compared to standard biopsy techniques.

Eligibility Criteria

Inclusion Criteria

Subjects is 18 years or older
Scheduled to undergo Endoscopic Retrograde Cholangiopancreatography (ERCP) wiht cholangioscopy and/or pancreatoscopy at the University of Florida Gainesville Florida as medically indicated.
Lesion of the pancreatobiliary system that requires tissue sampling as medically indicated
Subject myst be able to give informed consent

Exclusion Criteria

Any contraindication to Endoscopic Retrograde Cholangiopancreatography (ERCP)
The subject is unable to give informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01227382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.