N/A
N=242
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
Barrett Esophagus
Bottom Line
View on ClinicalTrials.gov: NCT02560623 ↗Enrolled (actual)
242
Serious AEs
2.5%
Results posted
Sep 2022
Primary outcome: Primary: Number of Subjects That Would Have This Procedure Again — 19; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biopsy (Procedure); Biospecimen Collection (Procedure); Endoscopic Procedure (Procedure); Swallowable Sponge Cell Sampling Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Would Have This Procedure Again |
19; 16 | — |
| PRIMARY Tolerability of Swallowing the Sponge Device |
1; 0.5; 1; 2; 2; 4.5 | — |
| PRIMARY Mucosal Irritation |
2; 1 | — |
| PRIMARY DNA Yield |
38.0; 30.8 | — |
| SECONDARY Sensitivity of Barrett's Dysplasia Detection |
92 | — |
| SECONDARY Specificity of Barrett's Dysplasia Detection |
94 | — |
Summary
This study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with Barrett's Esophagus compared to healthy controls.
Eligibility Criteria
Inclusion Criteria
Subjects with known Barrett's Esophagus (BE).
- Patients with a BE segment ≥ 1cm in maximal extent endoscopically.
- Histology showing evidence of intestinal metaplasia with or without presence of dysplasia.
- Undergoing clinically indicated endoscopy. Subjects without known evidence of BE - Undergoing clinically indicated diagnostic endoscopy
Exclusion Criteria
- Subjects with known BE.
- Patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). Patients with history of endoscopic mucosal resection alone will not be excluded.
- Patients with history of esophageal resection for esophageal carcinoma. Subjects with or without known evidence of BE (on history or review of medical records).
- Pregnant or lactating females.
- Patients who are unable to consent.
- Patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia.
- Patients on oral anticoagulation including Coumadin, Warfarin.
- Patients on antiplatelet agents including Clopidogrel, unless discontinued for 3 days prior to the sponge procedure.
- Patients on oral thrombin inhibitors including Dabigatran and oral factor X a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure.
- Patients with history of known varices or cirrhosis.
- Patients with history of esophageal resection for esophageal carcinoma.
- Patients with congenital or acquired bleeding diatheses.
- Patients with a history of esophageal squamous dysplasia.
- Patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.
Data sourced from ClinicalTrials.gov (NCT02560623). 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.