Clinical trial · Interventional
A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus
Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
NCT02560623CI-TRIAL-00062241completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsy | Procedure | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Endoscopic Procedure | Procedure | — | UNRESOLVED |
| Swallowable Sponge Cell Sampling Device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 1: Sponge on a String 25 mm 10 pores/inch
- description
- In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 10 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
- Procedure: Endoscopic Procedure
- Device: Swallowable Sponge Cell Sampling Device
- type
- EXPERIMENTAL
- label
- Phase 1: Sponge on a String 25 mm 20 pores/inch
- description
- In phase 1 of the study, subjects will be assigned to swallow a capsule sponge device 25 mm 20 pores/inch to collect cells and cellular material from the mucosa in the esophagus prior to scheduled for a clinically indicated upper endoscopy
- interventionNames
- Procedure: Biopsy
- Procedure: Biospecimen Collection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (3)
- DERIVEDIyer PG, Slettedahl SW, Mahoney DW, Giakoumopoulos M, Olson MC, Krockenberger M, Taylor WR, Foote P, Berger C, Leggett C, Wu TT, Antpack E, Falk GW, Ginsberg GG, Abrams JA, Lightdale CJ, Ramirez F, Kahn A, Wolfsen H, Konda V, Trindade AJ, Kisiel JB. Algorithm Training and Testing for a Nonendoscopic Barrett's Esophagus Detection Test in Prospective Multicenter Cohorts. Clin Gastroenterol Hepatol. 2024 Aug;22(8):1596-1604.e4. doi: 10.1016/j.cgh.2024.03.003. Epub 2024 Mar 19. PMID 38513982
- DERIVEDIyer PG, Taylor WR, Slettedahl SW, Lansing RL, Hemminger LL, Cayer FK, Mahoney DW, Giakoumopoulos M, Allawi HT, Wu TT, Wang KK, Wolfsen HC, Antpack E, Kisiel JB. Validation of a methylated DNA marker panel for the nonendoscopic detection of Barrett's esophagus in a multisite case-control study. Gastrointest Endosc. 2021 Sep;94(3):498-505. doi: 10.1016/j.gie.2021.03.937. Epub 2021 Apr 20. PMID 33857451
- DERIVEDIyer PG, Taylor WR, Johnson ML, Lansing RL, Maixner KA, Yab TC, Simonson JA, Devens ME, Slettedahl SW, Mahoney DW, Berger CK, Foote PH, Smyrk TC, Wang KK, Wolfsen HC, Ahlquist DA. Highly Discriminant Methylated DNA Markers for the Non-endoscopic Detection of Barrett's Esophagus. Am J Gastroenterol. 2018 Aug;113(8):1156-1166. doi: 10.1038/s41395-018-0107-7. Epub 2018 Jun 12. PMID 29891853