Colon AdenomaNCT01952418
Effect of Video Monitor Size on Adenoma Detection Rate
A study testing Monitor size in people with Colon Adenoma, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Colon Adenoma
- What is being tested?
- Monitor size
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,805 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2015
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
- Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit
Who cannot join
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.
Read the detailed description
Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.
- Conditions
- Colon Adenoma
- Being tested
- Monitor size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitor sizeDevice
Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor.
| Study group | Role | What they receive |
|---|---|---|
| Standard monitor (24") | No intervention | Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24"). |
| Large monitor (32") | Active comparator | Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32"). Receives: Device: Monitor size |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rate (All Indications)
Number of patients with adenoma detected
Measured: within 2 weeks (range of 1 day-14 days) of the endoscopy
Adenoma Detection Rate (Screening Exams Only)
Number of patients with adenoma detected
Measured: within 2 weeks (range of 1 day-14 days) of the endoscopy
Secondary outcomes (2)
Polyp Detection Rate (All Indications)
Number of patients with polyps detected
Measured: recorded during endoscopy (immediate)
Polyp Detection Rate (Screening Exams Only)
Number of patients with polyps detected
Measured: recorded during endoscopy (immediate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionJun 2015
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 (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norman Nishioka, MD, Massachusetts General Hospital
- Investigators
- Norman S Nishioka, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952418
- Sponsor's protocol ID
- 2013p001462
- Status last verified
- Apr 2017
- First submitted
- 19 Sep 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.
PubMed 30986402
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Monitor Size on Adenoma Detection Rate
- ClinicalTrials.gov ID
- NCT01952418
- Acronym / sponsor ID
- 2013p001462
- Conditions
- Colon Adenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,805 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Sep 2013 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.
Detailed description
Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard monitor (24") | No intervention | –Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24"). |
| Large monitor (32") | Active comparator | Device: Monitor sizeSubjects randomized to this group will perform colonoscopy while viewing a large video monitor (32"). |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
- Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit
Key exclusion criteria (1 listed)
- Refusal to participate
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 |
|---|---|---|
| Monitor sizeSubjects will be randomized to perform their colonoscopy procedures while viewing a large (32") video monitor or the standard (24") video monitor. | Device | Large monitor (32") |
Primary outcome
Adenoma Detection Rate (All Indications)
Time frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Number of patients with adenoma detected
Adenoma Detection Rate (Screening Exams Only)
Time frame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Number of patients with adenoma detected
2 secondary outcomes
Polyp Detection Rate (All Indications)
Time frame: recorded during endoscopy (immediate)
Polyp Detection Rate (Screening Exams Only)
Time frame: recorded during endoscopy (immediate)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30986402Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.
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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.
Norman S Nishioka, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitor size in people with Colon Adenoma, run by Massachusetts General Hospital 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 2 inclusion and 1 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 30 May 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 14 Apr 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?
Adenoma Detection Rate (All Indications) (time frame: within 2 weeks (range of 1 day-14 days) of the endoscopy). The study lists 2 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 NCT01952418, which also lists 1 linked publication.
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 30 May 2017.