Barrett EsophagusNCT03167970
Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy
An observational study of Barrett Esophagus, run by Midwest Biomedical Research at 1 site in United States.
Trial summary
This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Pill cam and EGD
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2017to 14 Jan 2018
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD.
Who may be able to join
- Patients age: ≥ 18 years
- Patients with BE length ≥ 1cm undergoing upper endoscopy
- Willingness to undergo both unsedated, capsule endoscopy and conventional EGD
- Ability to provide written, informed consent and understand the responsibilities of trial participation
Who cannot join
- Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- Pregnant or planning a pregnancy during the study period
- Dysphagia
- Known esophageal diverticulum or stricture
- Swallowing disorder
- Known luminal, gastrointestinal stricture
Show all 12Show fewer
- History of esophageal, gastric surgery
- Esophageal or GI motility disorder
- Subject has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines
- Known or suspected gastrointestinal obstruction, strictures, or fistulas based on the clinical picture or pre-procedure testing and profile.
- Subjects with cardiac pacemakers or other implanted electromedical devices.
- Anticipated magnetic resonance imaging within 1 week of capsule ingestion
Trial locations and contacts
1 site in 1 country.
United States1 site
Kansas City VA Medical Center
Kansas City, Missouri, 64128
About this study
Official title: Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy for Screening of Barrett's Esophagus: A Prospective Tandem Study
This study is to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.
Read the detailed description
This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study
Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.
The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.
- Conditions
- Barrett Esophagus
- Being tested
- Pill cam, EGD
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pill camDevice
Patient is asked to swallow the esophageal capsule.
EGDOther
Patient will undergo standard EGD
| Study group | Role | What they receive |
|---|---|---|
| Pill cam and EGD | Patients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD. Receives: Device: Pill cam; Other: EGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy
The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.
Measured: 1 year
Secondary outcomes (1)
Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy
Wireless capsule endoscopy is generally considered safe. Potential risks resulting from capsule endoscopy are reported low and may include discomfort while swallowing, accidental aspiration and capsule retention leading to small bowel obstruction and perforation. the investigator will measure tolerability of capsule endoscopy as well as standard endoscopy using visual analogue scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start3 May 2017
- Primary completion6 Dec 2017
- Study completion14 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Biomedical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Spine LLC
- Responsible party
- Sponsor
- Investigators
- Prateek Sharma, MD, Principal investigator, Kansas City VA Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03167970
- Sponsor's protocol ID
- PS0084
- Status last verified
- Jan 2018
- First submitted
- 4 Apr 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a funded study. A copy of de-identified data set will be provided to the sponsor in the form of case report forms (CRF) at the end of the study.
Publications
Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available.
PubMed 20032324Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005 Aug;39(7):572-8. doi: 10.1097/01.mcg.0000170764.29202.24.
PubMed 16000923Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396.
PubMed 22134936
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Performance Characteristics of Capsule Endoscopy With PillCam UGI Capsule Compared to Standard Endoscopy for Screening of Barrett's Esophagus: A Prospective Tandem Study
- ClinicalTrials.gov ID
- NCT03167970
- Acronym / sponsor ID
- PS0084
- Conditions
- Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Midwest Biomedical ResearchUniversity, hospital or other
- Collaborators
- Medtronic Spine LLC
- Study start
- 3 May 2017 (actual)
- Primary completion
- 6 Dec 2017 (actual)
- Study completion
- 14 Jan 2018 (actual)
- First posted
- 30 May 2017 (actual)
- Results
- Not posted in the source record
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 to examine the benefits of newly designed capsule with enhanced frame rate and wide angle compared to standard endoscopy, which may help enhance detecting esophageal diseases that otherwise may have been out of vision in the standard endoscopy, ultimately decreasing healthcare costs.
Detailed description
This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD. A member of the research team will approach a potential subject to discuss participation in the study, including background of the proposed study, inclusion and exclusion criteria, benefits and risks of the procedures and follow-up. If this is of interest to the subject, the informed consent form is discussed and presented. The subject must sign the consent form prior to enrollment. This form will have prior approval of the study site's Institutional Review Board (IRB). Failure to obtain informed consent renders the subject ineligible for the study
Eligible subjects at the participating institution who meet the inclusion criteria for this study will be offered the opportunity to participate in this clinical trial. To ensure that subjects are approached for potential study participation without bias, a Subject Screening Log will be maintained. This Log will track the basic demographic information of each subject approached for clinical trial inclusion and the resulting reason for exclusion from the clinical study if applicable.
The duration of the study is expected to be approximately 12 months. Enrollment of Study patients will cease when approximately 20 patients have been enrolled.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pill cam and EGD | – | Device: Pill cam, Other: EGDPatients in this arm is requested to swallow the esophageal capsule and then undergo standard EGD. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a pilot, single center, prospective, tandem study. All veteran patients with Barrett's esophagus scheduled for an upper EGD at Veterans Affairs Medical Center (Kansas City, MO, USA) for check-up of BE will be asked to swallow the pillcam prior to an EGD.
Key inclusion criteria (4 listed)
- Patients age: ≥ 18 years
- Patients with BE length ≥ 1cm undergoing upper endoscopy
- Willingness to undergo both unsedated, capsule endoscopy and conventional EGD
- Ability to provide written, informed consent and understand the responsibilities of trial participation
Key exclusion criteria (12 listed)
- Coagulopathy with INR > 1.5, thrombocytopenia with platelet counts < 50,000
- Pregnant or planning a pregnancy during the study period
- Dysphagia
- Known esophageal diverticulum or stricture
- Swallowing disorder
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 |
|---|---|---|
| Pill camPatient is asked to swallow the esophageal capsule. | Device | Pill cam and EGD |
| EGDPatient will undergo standard EGD | Other | Pill cam and EGD |
Primary outcome
The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy
Time frame: 1 year
The ability to accurately predict the presence of Barrett's esophagus by capsule endoscopy and standard EGD will be measured.
1 secondary outcome
Incidence of Treatment related adverse events of capsule endoscopy in comparison to standard esophagogastroduodenoscopy
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Background: PubMed 20032324Sharma P. Clinical practice. Barrett's esophagus. N Engl J Med. 2009 Dec 24;361(26):2548-56. doi: 10.1056/NEJMcp0902173. No abstract available.
- Background: PubMed 16000923Eliakim R, Sharma VK, Yassin K, Adler SN, Jacob H, Cave DR, Sachdev R, Mitty RD, Hartmann D, Schilling D, Riemann JF, Bar-Meir S, Bardan E, Fennerty B, Eisen G, Faigel D, Lewis BS, Fleischer DE. A prospective study of the diagnostic accuracy of PillCam ESO esophageal capsule endoscopy versus conventional upper endoscopy in patients with chronic gastroesophageal reflux diseases. J Clin Gastroenterol. 2005 Aug;39(7):572-8. doi: 10.1097/01.mcg.0000170764.29202.24.
- Background: PubMed 22134936Chang JY, Talley NJ, Locke GR 3rd, Katzka DA, Schleck CD, Zinsmeister AR, Dunagan KT, Wu TT, Wang KK, Prasad GA. Population screening for barrett esophagus: a prospective randomized pilot study. Mayo Clin Proc. 2011 Dec;86(12):1174-80. doi: 10.4065/mcp.2011.0396.
- Individual participant dataSharing planned: No. This is a funded study. A copy of de-identified data set will be provided to the sponsor in the form of case report forms (CRF) at the end of the 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.
Prateek Sharma, MD principal investigator
Kansas City VA Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett Esophagus, run by Midwest Biomedical Research 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 4 inclusion and 12 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 19 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The overall diagnostic accuracy of capsule endoscopy in predicting the presence and extent of Barrett's esophagus in comparison to standard esophagogastroduodenoscopy (time frame: 1 year). 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 NCT03167970, 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 19 Jan 2018.