Cytosponge Adequacy Study Evaluation II

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2018-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnosis and Monitoring of Eosinophilic Esophagitis Using the Cytosponge

NCT02114606

Eosinophilic Esophagitis EoE

TERMINATED NA

Patient Acceptance and Preference Among Screening Modalities for Detection of Barrett's Esophagus

NCT04301986

Barrett Esophagus GERD

COMPLETED NA

Comparison of Histology From a Mesh Sponge and Traditional Esophageal Biopsies in Children and Adolescents With EoE

NCT05342168

Eosinophilic Esophagitis

UNKNOWN NA

Mucosal Impedance Balloon in Diagnosis and Treatment of Eosinophilic Esophagitis (EoE)

NCT02995395

Eosinophilic Esophagitis Healthy

COMPLETED

Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

NCT00526786

Barrett's Esophagus High Grade Dysplasia Low Grade Dysplasia

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a cross-sectional study of subjects with Barrett's esophagus (BE) to assess the utility of the Cytosponge device as a non-endoscopic method for collecting surface cells from the esophagus. This study will enroll 2 groups of subjects: 1) Subjects presenting for routine endoscopic BE surveillance examinations (n=120), and 2) Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE (n=55). After informed consent, and on the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge device and complete a questionnaire. The subject will then undergo routine upper endoscopy, with assessment of BE (where applicable), and biopsy per accepted surveillance or screening recommendations. The Cytosponge will be placed in fixative and shipped to an accredited pathology laboratory for embedding in paraffin and hematoxylin and eosin (H\&E) staining to assess the adequacy of the specimen. Further evaluation of the specimen may be performed using trefoil factor 3 (TFF3). If the Cytosponge tissue specimen is inadequate, the subject will be recalled for a repeat sponge procedure (not endoscopy) 30 days later. Routine care tissue biopsies will undergo standard processing and H\&E staining at the home institution, with assessment by expert gastrointestinal pathologists. Subjects will be contacted via phone 7 days (+/- 2 days) after Cytosponge administration to complete additional questionnaires and assess adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Barrett's Esophagus GERD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patient wth Barrett's

Subjects presenting for routine endoscopic BE surveillance examinations

Group Type EXPERIMENTAL

Cytosponge™ Cell Collection Device

Intervention Type DEVICE

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Patients with GERD

Subjects with gastroesophageal reflux disease (GERD) symptoms undergoing upper endoscopy for screening for BE

Group Type EXPERIMENTAL

Cytosponge™ Cell Collection Device

Intervention Type DEVICE

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cytosponge™ Cell Collection Device

Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or female subjects, age 18 and above.
2. Able to read, comprehend, and complete the consent form.
3. Clinically fit for an endoscopy.

Exclusion Criteria

1. Individuals with a diagnosis of an oropharynx, esophageal or gastro-esophageal tumor, or symptoms of dysphagia.
2. Any history of esophageal varices, stricture, or prior dilation of the esophagus.
3. Current use of anti-thrombotics (anti-coagulants and anti-platelet drugs) that cannot be safely discontinued for the appropriate drug-specific interval in the peri-administration period. Depending on the particular agent or reason for the anti-thrombotic therapy, it may not be necessary to discontinue anti-thrombotic agents. There could be circumstances where the drug may not need to be discontinued if the risk of bleeding is considered negligible (e.g. daily aspirin therapy). Physicians should use their clinical judgement and should consult guidelines such as those provided by the ASGE.
4. Known bleeding disorder.
5. Individuals who have had a myocardial infarction or any cardiac event \< 6 months prior to enrollment.
6. Individuals who have had a cerebrovascular event \< 6 months prior to enrollment in which swallowing was affected.
7. Prior ablative or resection therapy of the esophagus including radiofrequency ablation (RFA), photodynamic therapy (PDT), spray cryotherapy, endoscopic mucosal resection, and other ablation therapies.
8. Any history of esophageal surgery, except for uncomplicated fundoplication.
9. Do not need upper endoscopy as part of patient management.
10. Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes