Barrett EsophagusNCT02560623

A Minimally-Invasive Sponge on a String Device for Screening for Barrett's Esophagus

A study testing Biopsy, Biospecimen Collection and Endoscopic Procedure in people with Barrett Esophagus, run by Mayo Clinic at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: Barrett Esophagus
What is being tested?: Biopsy, Biospecimen Collection and Endoscopic Procedure
Type of treatment: Pill or oral medicine, Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 242 participants
Where: 6 sitesUnited States
Study dates: 15 Oct 2015to 8 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Show all 14Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Baylor University Medical Center
Dallas, Texas, 75246
Mayo Clinic
Jacksonville, Florida, 32224
Northwell Health
Manhasset, New York, 11030
Mayo Clinic Health System - Mankato
Mankato, Minnesota, 56001
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Mayo Clinic
Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device

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.

Read the detailed description

This study will be conducted in two phases: Phase 1 and Phase 2. Phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and DNA yield, using a randomized factorial design pilot trial. Participants will first undergo the sponge on a string test followed by clinical endoscopy. Following completion of Phase 1 trial, the most optimal sponge on a string configuration will be chosen for Phase 2. Phase 2 will be conducted using a single size sponge with the same porosity configuration selected from Phase 1. Study procedures, testing and follow up will be the same as Phase 1.

Conditions: Barrett Esophagus
Being tested: Biopsy, Biospecimen Collection, Endoscopic Procedure, Swallowable Sponge Cell Sampling Device
Keywords: Barrett's, esophagus, reflux, esophageal adenocarcinoma
Medical subject headings: Barrett Esophagus, Gastroesophageal Reflux, Adenocarcinoma Of Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BiopsyProcedure or surgery
Also called BIOPSY_TYPE, Bx
Undergo biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo collection of blood sample
Endoscopic ProcedureProcedure or surgery
Also called Endoscopic Examination, Endoscopy
Undergo endoscopy
Swallowable Sponge Cell Sampling DeviceDevice
Also called Cytosponge, Swallowable Sponge, Swallowable Sponge Device
Undergo swallowable sponge cell sampling assessment

Study groups in NCT02560623
Study group	Role	What they receive
Phase 1: Sponge on a String 25 mm 10 pores/inch	Experimental	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 Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device
Phase 1: Sponge on a String 25 mm 20 pores/inch	Experimental	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 Receives: Procedure: Biopsy; Procedure: Biospecimen Collection; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device
Phase 2: Cases - Barrett's Esophagus	Experimental	In phase 2 of the study, additional 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 Receives: Procedure: Biopsy; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device
Phase 2: Controls - No Barrett's Esophagus	Experimental	In phase 2 of the study, additional 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 Receives: Procedure: Biopsy; Procedure: Endoscopic Procedure; Device: Swallowable Sponge Cell Sampling Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects That Would Have This Procedure Again
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Measured: Within 24 hours of the capsule sponge administration
Tolerability of Swallowing the Sponge Device
Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.
Measured: Within 24 hours of the capsule sponge administration
Mucosal Irritation
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
Measured: Within 24 hours of the capsule sponge administration
DNA Yield
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.
Measured: Within 24 hours of the capsule sponge administration

Secondary outcomes (2)

Sensitivity of Barrett's Dysplasia Detection
The sensitivity methylated DNA markers detected by the capsule sponge, in making a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
Measured: Within 24 hours of the capsule sponge administration
Specificity of Barrett's Dysplasia Detection
The specificity of methylated DNA markers detected by the capsule sponge, in identifying subjects without a diagnosis of BE related dysplasia will be assessed using endoscopic surveillance biopsy histology as a gold standard.
Measured: Within 24 hours of the capsule sponge administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 20158 Jul 2021

First posted25 Sep 2015 (estimated)
Study start15 Oct 2015
Primary completion29 Jun 2021
Study completion8 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Barrett EsophagusStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02560623
Sponsor's protocol ID: 15-004540
Other IDs: NCI-2022-08390, 15-004540, P30CA015083
Status last verified: Nov 2022
First submitted: 21 Sep 2015
Last updated: 17 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Iyer 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.
PubMed 38513982
Iyer 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.
PubMed 33857451
Iyer 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.
PubMed 29891853

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Active, not recruitingObservational study
Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus, Barretts Esophagus With Dysplasia
Active, not recruiting
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule
Barrett's Esophagus
Active, not recruiting
Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy
Barrett Esophagus

All Barrett Esophagus trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma by a Sponge on String Device
ClinicalTrials.gov ID: NCT02560623
Acronym / sponsor ID: 15-004540
Conditions: Barrett Esophagus
Keywords: Barrett's, esophagus, reflux, esophageal adenocarcinoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), Exact Sciences Corporation
Study start: 15 Oct 2015 (actual)
Primary completion: 29 Jun 2021 (actual)
Study completion: 8 Jul 2021 (actual)
First posted: 25 Sep 2015 (estimated)
Results: Posted 16 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Screening
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Phase 1: Sponge on a String 25 mm 10 pores/inch	Experimental	Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Endoscopic Procedure, Device: Swallowable Sponge Cell Sampling DeviceIn 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
Phase 1: Sponge on a String 25 mm 20 pores/inch	Experimental	Procedure: Biopsy, Procedure: Biospecimen Collection, Procedure: Endoscopic Procedure, Device: Swallowable Sponge Cell Sampling DeviceIn 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
Phase 2: Cases - Barrett's Esophagus	Experimental	Procedure: Biopsy, Procedure: Endoscopic Procedure, Device: Swallowable Sponge Cell Sampling DeviceIn phase 2 of the study, additional 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
Phase 2: Controls - No Barrett's Esophagus	Experimental	Procedure: Biopsy, Procedure: Endoscopic Procedure, Device: Swallowable Sponge Cell Sampling DeviceIn phase 2 of the study, additional 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

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (14 listed)

Subjects with known BE.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BiopsyAlso: BIOPSY_TYPE, BxUndergo biopsy	Procedure or surgery	Phase 1: Sponge on a String 25 mm 10 pores/inch, Phase 1: Sponge on a String 25 mm 20 pores/inch, Phase 2: Cases - Barrett's Esophagus, Phase 2: Controls - No Barrett's Esophagus
Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo collection of blood sample	Procedure or surgery	Phase 1: Sponge on a String 25 mm 10 pores/inch, Phase 1: Sponge on a String 25 mm 20 pores/inch
Endoscopic ProcedureAlso: Endoscopic Examination, EndoscopyUndergo endoscopy	Procedure or surgery	Phase 1: Sponge on a String 25 mm 10 pores/inch, Phase 1: Sponge on a String 25 mm 20 pores/inch, Phase 2: Cases - Barrett's Esophagus, Phase 2: Controls - No Barrett's Esophagus
Swallowable Sponge Cell Sampling DeviceAlso: Cytosponge, Swallowable Sponge, Swallowable Sponge DeviceUndergo swallowable sponge cell sampling assessment	Device	Phase 1: Sponge on a String 25 mm 10 pores/inch, Phase 1: Sponge on a String 25 mm 20 pores/inch, Phase 2: Cases - Barrett's Esophagus, Phase 2: Controls - No Barrett's Esophagus

Primary outcome

Number of Subjects That Would Have This Procedure Again
Time frame: Within 24 hours of the capsule sponge administration
Number of subjects that answered yes to the self-reported question "Would you choose to have this procedure again to screen for Barrett's esophagus?"
Tolerability of Swallowing the Sponge Device
Time frame: Within 24 hours of the capsule sponge administration
Measured using a self-reported 5-item tolerability assessment rating discomfort during the procedure on a Likert scale of 0-10; 10 representing the "worst experience" and 0 the "best experience." This scale allows a comprehensive and individual assessment of the degree of pain, choking, gagging, anxiety and overall experienced during the procedure.
Mucosal Irritation
Time frame: Within 24 hours of the capsule sponge administration
Measured using a mucosal injury score (ranging from 1=no trauma to 5=severe) was scored from video recordings of the subsequent endoscopy conducted
DNA Yield
Time frame: Within 24 hours of the capsule sponge administration
Total amount of DNA obtained from esophageal cytology specimens collected by the capsule sponge devices.

2 secondary outcomes

Sensitivity of Barrett's Dysplasia Detection
Time frame: Within 24 hours of the capsule sponge administration
Specificity of Barrett's Dysplasia Detection
Time frame: Within 24 hours of the capsule sponge administration

Results and safety

Results posted to the registry on 16 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1: Sponge on a String 25 mm 10 Pores/Inch	19	19
Phase 1:Sponge on a String 25 mm 20 Pores/Inch	22	20
Phase 2: Cases - Barrett's Esophagus	112	112
Phase 2: Controls - No Barrett's Esophagus	89	89

Primary outcome: Number of Subjects That Would Have This Procedure Again

Time frame: Within 24 hours of the capsule sponge administration. Count of participants. Unit: Participants

Measure	Phase 1: Sponge on a String 25 mm 10 Pores/Inch n = 19	Phase 1:Sponge on a String 25 mm 20 Pores/Inch n = 20
Value	19	16

Population analysed: Data collected and analyzed for only Phase 1: Sponge on a String 25 mm 10 pores/inch group and Phase 1:Sponge on a String 25 mm 20 pores/inch as this outcome is specific for phase 1 of the study only

Primary outcome: Tolerability of Swallowing the Sponge Device

Time frame: Within 24 hours of the capsule sponge administration. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Phase 1: Sponge on a String 25 mm 10 Pores/Inch n = 19	Phase 1:Sponge on a String 25 mm 20 Pores/Inch n = 20
Pain	1 (0 to 1.5)	0.5 (0 to 2)
Choking	1 (0 to 2.5)	2 (1 to 4.25)
Gagging	2 (1 to 6)	4.5 (2 to 5.5)
Anxiety	0 (0 to 1)	1 (0 to 2.5)
Overall	0 (0 to 1)	1.5 (0 to 5.25)

Primary outcome: Mucosal Irritation

Time frame: Within 24 hours of the capsule sponge administration. Median (Full Range). Unit: score on a scale

Measure	Phase 1: Sponge on a String 25 mm 10 Pores/Inch n = 19	Phase 1:Sponge on a String 25 mm 20 Pores/Inch n = 20
Value	2 (1 to 2)	1 (1 to 2)

Primary outcome: DNA Yield

Time frame: Within 24 hours of the capsule sponge administration. Median (Inter-Quartile Range). Unit: μg

Measure	Phase 1: Sponge on a String 25 mm 10 Pores/Inch n = 19	Phase 1:Sponge on a String 25 mm 20 Pores/Inch n = 20
Value	38.0 (28.5 to 51.5)	30.8 (26.1 to 41.8)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from baseline to end of study at approximately seven days after research procedure on all participants.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1: Sponge on a String 25 mm 10 Pores/Inch	0 of 19 (0%)	5 of 19 (26.3%)	0 of 19
Phase 1:Sponge on a String 25 mm 20 Pores/Inch	0 of 22 (0%)	8 of 22 (36.4%)	0 of 22
Phase 2: Cases - Barrett's Esophagus	5 of 112 (4.5%)	31 of 112 (27.7%)	0 of 112
Phase 2: Controls - No Barrett's Esophagus	1 of 89 (1.1%)	30 of 89 (33.7%)	0 of 89

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38513982Iyer 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.
Derived from this study: PubMed 33857451Iyer 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.
Derived from this study: PubMed 29891853Iyer 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.
Individual participant dataSharing planned: No

Related trials for Barrett Esophagus

Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Prasad G Iyer, M.D. principal investigator

Mayo Clinic in Rochester

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Biopsy, Biospecimen Collection and Endoscopic Procedure in people with Barrett Esophagus, run by Mayo Clinic at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects That Would Have This Procedure Again (time frame: Within 24 hours of the capsule sponge administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02560623, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.