Esophageal LesionCEPELANCT00990782
Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
A study testing PillCam ESO Capsule Endoscope in people with Esophageal Lesion, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Lesion
- What is being tested?
- PillCam ESO Capsule Endoscope
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- Adults aged 18 years and older
- Patients able to give informed consent
Who cannot join
- Patients under the age of 18
- Patient unable to or unwilling to swallow the capsule endoscopes
- Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
- Pregnant or lactating females
- Subjects with history of abdominal, pelvic, or bowel surgery within the past year
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
Read the detailed description
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
- Conditions
- Esophageal Lesion
- Being tested
- PillCam ESO Capsule Endoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam ESO Capsule EndoscopeDiagnostic test
Utilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | PillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure. Receives: Diagnostic Test: PillCam ESO Capsule Endoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
Measured: 14 days
Secondary outcomes (1)
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionSep 2010
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.
- Other trials for Esophageal LesionStudies of the same condition, open and under way.
- More trials run by The Cleveland 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Milan Dodig, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00990782
- Sponsor's protocol ID
- 08-634
- Acronym
- CEPELA
- Status last verified
- May 2017
- First submitted
- 6 Oct 2009
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEPELA I Trial: Capsule Endoscopy for Post-Ablation Esophageal Lesion Assessment
- ClinicalTrials.gov ID
- NCT00990782
- Acronym / sponsor ID
- CEPELA / 08-634
- Conditions
- Esophageal Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 7 Oct 2009 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
Detailed description
Patients undergoing radiofrequency ablation (RFA) therapy for atrial fibrillation, can sometimes experience insult or injury to the esophagus, due to the proximity of the esophagus to the RFA treatment area. This study utilizes a disposable capsule endoscope (Pillcam ESO) to assess the condition of a patient's esophagus before and after the RFA procedure, as the injury rate to the esophagus has not been established.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Diagnostic Test: PillCam ESO Capsule EndoscopePillCam ESO Capsule Endoscope - all patients receive capsule endoscopy before and after RFA procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic patients with persistent atrial fibrillation selected for radiofrequency ablation
- Adults aged 18 years and older
- Patients able to give informed consent
Key exclusion criteria (5 listed)
- Patients under the age of 18
- Patient unable to or unwilling to swallow the capsule endoscopes
- Patients with cardiac pacemakers, implanted cardiac defibrillators or other implanted electro-medical devices
- Pregnant or lactating females
- Subjects with history of abdominal, pelvic, or bowel surgery within the past year
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 |
|---|---|---|
| PillCam ESO Capsule EndoscopeUtilization of the PillCam ESO capsule endoscope to evaluate the condition of a patient's esophagus before and after RFA therapy to treat atrial fibrillation. | Diagnostic test | Single Arm |
Primary outcome
Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy
Time frame: 14 days
1 secondary outcome
Number of Participants With Capsule-identified Esophageal Injury Who Report Symptoms Post-RFA
Time frame: 14 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Milan Dodig, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam ESO Capsule Endoscope in people with Esophageal Lesion, run by The Cleveland Clinic 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?
The sponsor lists 3 inclusion and 5 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 2 Jul 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2017). 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 Participants With Esophageal Lesions Identified Using Capsule Endoscopy (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2017.