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Esophageal CancerPhase 1/2NCT00903136

Tethered Capsule Endoscope in Screening Participants for Barrett Esophagus

A Phase 1/2 study testing questionnaire administration, comparison of screening methods and diagnostic endoscopic procedure in people with Esophageal Cancer and Precancerous Condition, run by US Department of Veterans Affairs at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus. PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Esophageal Cancer, Precancerous Condition
What is being tested?
questionnaire administration, comparison of screening methods and diagnostic endoscopic procedure
How many people
50 participants
Where
1 siteUnited States
Study dates
May 2009to Dec 2011
Phase
Phase 1/2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Meets one of the following criteria:
  • Healthy participant (phase I)
  • Scheduled to undergo esophagogastroduodenoscopy at the VA Puget Sound Health Care System for the evaluation of reflux symptoms (including screening for Barrett esophagus [BE]) or for follow-up of known BE (phase II)
  • No current diagnosis of cancer

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Able to fast for ≥ 6 hours prior to scheduled appointment
  • No symptoms of dysphagia
  • No history of a swallowing disorder (e.g., scleroderma, achalasia, esophageal stricture, or esophageal diverticulum)
  • No history of a known or suspected gastrointestinal (GI) obstruction
  • No other major medical illnesses (e.g., unstable cardiovascular disease, end-stage liver or kidney disease, or suspected active GI bleeding)
  • No major physical disability that would prevent the participant from transferring from a chair to a bed and sitting up
  • Not planning to undergo an MRI within 2 weeks after the study procedure

PRIOR CONCURRENT THERAPY:

  • No prior surgery on the oropharynx, neck, esophagus, or stomach
  • No concurrent anticoagulant medications or clopidogrel

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • Veterans Affairs Medical Center - Seattle

    Seattle, Washington, 98108

    Jason A. Dominitz, MD, 206-764-2285

    Recruiting

Other trials in United States

About this study

Official title: Screening for Barrett's Esophagus With an Ultrathin Scanning Fiber Endoscope

RATIONALE: A tethered capsule endoscope may be as effective as standard sedated endoscopy of the esophagus, stomach, and duodenum in screening for Barrett esophagus.

PURPOSE: This phase I/II trial is studying how well a tethered capsule endoscope works in screening participants for Barrett esophagus.

Read the detailed description

OBJECTIVES:

  • To determine the clinical feasibility of obtaining endoscopic esophageal images using a tethered capsule endoscope (TCE). (Phase I)
  • To determine the optimal weight and possibly shape for rapid patient ingestion and extraction of the TCE. (Phase I)
  • To determine the optimal tether design (e.g., rigidity, distance markings, and other material properties). (Phase I)
  • To determine the optimal protocol for patient ingestion and extraction of the TCE. (Phase I)
  • To compare the TCE to standard sedated esophagogastroduodenoscopy for identifying suspected Barrett esophagus. (Phase II)

OUTLINE:

  • Phase I: Participants swallow the tethered capsule endoscope (TCE) so that the distal end of the TCE enters the stomach. The TCE is then slowly withdrawn by the physician in order to visualize the gastroesophageal junction and the esophagus in a retrograde fashion until the upper esophageal sphincter is reached. The image acquisition process is repeated and the participant may be asked to swallow the TCE in up to 7 different positions with 2 swallows per position (no more than 20 swallows total).
  • Phase II: Participants undergo TCE as in phase I, followed by standard sedated esophagogastroduodenoscopy (EGD) by a second physician.

Images obtained via TCE and EGD are reviewed by a third physician blinded to the results of each exam.

In both phases, participants and physicians complete a questionnaire after the TCE procedure to determine the ease of the procedure. Participants are also asked for specific suggestions to improve the TCE experience. Participants enrolled in phase II also complete a questionnaire 1 week after EGD to compare the TCE procedure with the EGD.

Being tested
questionnaire administration, comparison of screening methods, diagnostic endoscopic procedure, esophagogastroduodenoscopy, tethered capsule endoscopy
Keywords
Barrett esophagus, esophageal cancer, adenocarcinoma of the esophagus
Medical subject headings
Esophageal Neoplasms, Precancerous Conditions, Barrett Esophagus, Adenocarcinoma Of Esophagus

What participants receive

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

  • questionnaire administrationOther

  • comparison of screening methodsProcedure or surgery

  • diagnostic endoscopic procedureProcedure or surgery

  • esophagogastroduodenoscopyProcedure or surgery

  • tethered capsule endoscopyProcedure or surgery

What is being measured

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

  1. Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I)

  2. Time required to image the squamo-columnar junction (Phase I)

  3. Number of repeated swallows to achieve esophageal imaging (Phase I)

  4. Amount of simethicone needed to reduce bubbles (Phase I)

  5. Need for effervescent granules or other approaches to distend the esophagus (Phase I)

  6. Time required for the entire TCE procedure (Phase I)

  7. Quality of images (clarity, color, field of view, and resolution) obtained in the entire TCE procedure (Phase I)

  8. Overall comfort during ingestion, pullback, and withdrawal of the TCE (Phase I)

  9. Sensitivity, specificity, and accuracy of the TCE for identifying suspected Barrett esophagus (Phase II)

  10. Agreement between the findings on the live TCE exam with the recorded TCE exam (Phase II)

  11. Time to perform the TCE exam (Phase II)

  12. Test characteristics of the first half vs the last half of the TCE exams performed by each of the 2 endoscopists (Phase II)

  13. Comparison of participants' satisfaction with the TCE vs esophagogastroduodenoscopy (Phase II)

Secondary outcomes (2)

  1. Ability of the TCE to identify the presence or absence of other esophageal lesions (e.g., inflammation, diverticula, or varices) (Phase II)

  2. Results of the histologic analysis of any biopsy specimens (Phase II)

Timeline

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

  1. First posted18 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionDec 2011 (estimated)

Resources

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 1/2
Primary purpose
Screening
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00903136
Sponsor's protocol ID
CDR0000641937
Other IDs
VAMC-WA-33141
Status last verified
Feb 2010
First submitted
15 May 2009
Last updated
10 Jan 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing questionnaire administration, comparison of screening methods and diagnostic endoscopic procedure in people with Esophageal Cancer and Precancerous Condition, run by US Department of Veterans Affairs at 1 site 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?

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: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time required for swallowing the tethered capsule endoscope (TCE) to the stomach (Phase I). The study lists 13 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 NCT00903136.

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 10 Jan 2014.

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