Barrett EsophagusNCT03191604
Impact of NBI on Patients Undergoing Endoscopic Eradication Therapy
An observational study of Barrett Esophagus, run by Northwestern University at 1 site in United States.
Trial summary
This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy (EET). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett Esophagus
- What is being tested?
- Video intervention
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 10 May 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Endoscopist sub-groups include academic endoscopists performing greater than 50 EET procedures per year, community endoscopists performing greater than 50 EET procedures per year, 25 academic gastroenterologists performing greater than 500 upper endoscopies per year not including EET, and 25 community gastroenterologists performing greater than 500 upper endoscopies per year not including EET.
Who may be able to join
- Endoscopists familiar with EET.
Who cannot join
- Endoscopists not familiar with EET or non-endoscopists.
- Special populations will not be included in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Study Evaluating the Impact of NBI on Patients With Barrett's Esophagus Associated Neoplasia Undergoing Endoscopic Eradication Therapy (EET)
This study tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy (EET).
Read the detailed description
Barrett's esophagus (BE), is a condition whereby normal esophageal squamous epithelium is replaced by metaplastic columnar epithelium, predisposing patients to esophageal adenocarcinoma (EAC). It is estimated that about 5.6% of adults in the United States have BE with risk factors including: long standing gastroesophageal reflux disease, tobacco use, male gender, central obesity, and age over 50 years. EAC is believed to progress in a step-wise pattern with the following order of non-dysplastic BE, low-grade dysplasia (LGD), and high-grade dysplasia (HGD). Each carries a risk of progression to EAC, differing by degree of dysplasia: 0.2-0.5%, 0.7%, and 7% per year, respectively. Given this association, it is common practice to perform endoscopic surveillance with biopsies in patients with BE. Endoscopic surveillance has been shown to detect EAC at earlier stages and improve survival in asymptomatic presentations. As dysplasia in BE may not always be seen as a distinct lesion, surveillance programs entail use of the Seattle Protocol, a systematic four-quadrant biopsy technique obtained at 1 to 2 cm increments. Current guidelines recommend the use of high-definition white light endoscopy (HD-WLE) as it is superior over standard-definition in regards to improved targeted detection of dysplasia.
Advanced endoscopic imaging techniques have been proposed to improve dysplasia detection with preference for electronic chromoendoscopy, specifically narrow band imaging (NBI), as it does not require dye sprays. NBI has been shown to be more accurate in detecting intestinal metaplasia and HGD. HGD is more often detected in areas with subtle mucosal and vascular abnormalities, which may be more difficult to see on HD-WLE alone. However, subtle lesions may go undetected, as NBI is not routinely used in the community with a recent survey showing only about a third of practicing gastroenterologists use advanced endoscopic imaging. The widespread use of NBI has been potentially limited by a perceived complexity of interpretation and lack of standardization. Recently, Sharma et al introduced the BING criteria - a standardized classification system to detect dysplasia and EAC with NBI. While a few studies have demonstrated no significant difference in detection of dysplasia or neoplasia between HD-WLE and NBI, they have had some limitations. The studies occurred prior to the BING classification system, and participants were limited to a few expert tertiary medical centers.
The current standard of care for visible lesions identified by HD-WLE (nodules, ulcers, erosions, or plaques) is endoscopic mucosal resection (EMR). Endoscopic recognition and appropriate resection of visible lesions is essential for optimal patient outcomes. Staging EMR is critical as it allows for histopathological "upgrading" or "downgrading" of dysplasia and ultimately is the best tool for identifying and treating early EAC. Despite the importance of EMR for BE-AN, survey data suggests it is underutilized in practice with 39% of academic endoscopists and 13% of community-based endoscopists performing EMR. While many endoscopists utilize NBI to assist in identification of visible lesions, the resection of areas deemed "abnormal" by NBI alone is not widely accepted. Moreover, endoscopists at community hospitals detect neoplastic lesions at significantly lower rates than at BE expert centers.
Given these data, routine use of NBI prior to EET could significantly impact treatment decisions among all endoscopists with highly accurate rates of dysplasia detection. It's been shown that NBI increases the accuracy and positive predictive value of predicting histology than if HD-WLE is used alone. This study is limited by the use of still-images, which does not accurately reproduce live images seen during endoscopy. Nevertheless, the current standard of using HD-WLE for identification of visible lesions likely underestimates the presence of dysplastic areas in patients undergoing Endoscopic Eradication Therapy (EET) for BE-AN. We hypothesize that the routine use of narrow band imaging (NBI) for identification of visible lesions will improve dysplasia detection and have a significant effect on the choice of primary treatment modality among endoscopists performing EET. To this end, we propose a video-based study to evaluate the impact of NBI on choice of treatment modality during EET.
- Conditions
- Barrett Esophagus
- Being tested
- Video intervention
- Keywords
- Endoscopy, Narrow band imaging, Dysplasia
- Medical subject headings
- Barrett Esophagus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video interventionOther
Video clips of endoscopy footage with just HD-WLE and clips with NBI will be shown to endoscopists.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopists familiar with EET | Physicians familiar with conducting endoscopic eradication therapy. Receives: Other: Video intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered chosen treatment modality due to NBI
Percentage of cases in which use of NBI altered decision-making in regards to initial treatment modality for patients undergoing EET.
Measured: 1 year
Secondary outcomes (3)
% visable dysplastic lesions detected
Percentage of visible dysplastic lesions detected by HD-WLE and NBI across all participants stratified by subgroup of experience
Measured: 1 year
Accurate pathology assessment
Accuracy of pathology assessment by endoscopists using HD-WLE and NBI in patients undergoing EMR
Measured: 1 year
Differences in pathology identification between subgroups
Differences in identification of pathology based on subgroup of experience, volume of EET, and type of practice.
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 posted19 Jun 2017
- Study start1 Nov 2017
- Primary completion10 May 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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 Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sri Komanduri, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191604
- Sponsor's protocol ID
- STU00205021
- Status last verified
- Nov 2019
- First submitted
- 15 Jun 2017
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
PubMed 25162890Hayeck TJ, Kong CY, Spechler SJ, Gazelle GS, Hur C. The prevalence of Barrett's esophagus in the US: estimates from a simulation model confirmed by SEER data. Dis Esophagus. 2010 Aug;23(6):451-7. doi: 10.1111/j.1442-2050.2010.01054.x. Epub 2010 Mar 26.
PubMed 20353441Ireland CJ, Thompson SK, Laws TA, Esterman A. Risk factors for Barrett's esophagus: a scoping review. Cancer Causes Control. 2016 Mar;27(3):301-23. doi: 10.1007/s10552-015-0710-5. Epub 2016 Feb 5.
PubMed 26847374Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3.
PubMed 26526079Incarbone R, Bonavina L, Saino G, Bona D, Peracchia A. Outcome of esophageal adenocarcinoma detected during endoscopic biopsy surveillance for Barrett's esophagus. Surg Endosc. 2002 Feb;16(2):263-6. doi: 10.1007/s00464-001-8161-3. Epub 2001 Nov 16.
PubMed 11967675Ferguson MK, Durkin A. Long-term survival after esophagectomy for Barrett's adenocarcinoma in endoscopically surveyed and nonsurveyed patients. J Gastrointest Surg. 2002 Jan-Feb;6(1):29-35; discussion 36. doi: 10.1016/s1091-255x(01)00052-x.
PubMed 11986015Fountoulakis A, Zafirellis KD, Dolan K, Dexter SP, Martin IG, Sue-Ling HM. Effect of surveillance of Barrett's oesophagus on the clinical outcome of oesophageal cancer. Br J Surg. 2004 Aug;91(8):997-1003. doi: 10.1002/bjs.4591.
PubMed 15286961van Sandick JW, van Lanschot JJ, Kuiken BW, Tytgat GN, Offerhaus GJ, Obertop H. Impact of endoscopic biopsy surveillance of Barrett's oesophagus on pathological stage and clinical outcome of Barrett's carcinoma. Gut. 1998 Aug;43(2):216-22. doi: 10.1136/gut.43.2.216.
PubMed 10189847Fitzgerald RC, Saeed IT, Khoo D, Farthing MJ, Burnham WR. Rigorous surveillance protocol increases detection of curable cancers associated with Barrett's esophagus. Dig Dis Sci. 2001 Sep;46(9):1892-8. doi: 10.1023/a:1010678913481.
PubMed 11575441Abela JE, Going JJ, Mackenzie JF, McKernan M, O'Mahoney S, Stuart RC. Systematic four-quadrant biopsy detects Barrett's dysplasia in more patients than nonsystematic biopsy. Am J Gastroenterol. 2008 Apr;103(4):850-5. doi: 10.1111/j.1572-0241.2007.01746.x. Epub 2008 Mar 26.
PubMed 18371135Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.
PubMed 25209721Song J, Zhang J, Wang J, Guo X, Yu S, Wang J, Liu Y, Dong W. Meta-analysis of the effects of endoscopy with narrow band imaging in detecting dysplasia in Barrett's esophagus. Dis Esophagus. 2015 Aug-Sep;28(6):560-6. doi: 10.1111/dote.12222. Epub 2014 Apr 24.
PubMed 24758693Jayasekera C, Taylor AC, Desmond PV, Macrae F, Williams R. Added value of narrow band imaging and confocal laser endomicroscopy in detecting Barrett's esophagus neoplasia. Endoscopy. 2012 Dec;44(12):1089-95. doi: 10.1055/s-0032-1325734. Epub 2012 Nov 27.
PubMed 23188660Singh M, Gupta N, Gaddam S, Balasubramanian G, Wani S, Sinh P, Aghaie K, Higbee AD, Rastogi A, Kanakadandi V, Bansal A, Sharma P. Practice patterns among U.S. gastroenterologists regarding endoscopic management of Barrett's esophagus. Gastrointest Endosc. 2013 Nov;78(5):689-95. doi: 10.1016/j.gie.2013.05.002. Epub 2013 Jun 14.
PubMed 23769458Sharma P, Bergman JJ, Goda K, Kato M, Messmann H, Alsop BR, Gupta N, Vennalaganti P, Hall M, Konda V, Koons A, Penner O, Goldblum JR, Waxman I. Development and Validation of a Classification System to Identify High-Grade Dysplasia and Esophageal Adenocarcinoma in Barrett's Esophagus Using Narrow-Band Imaging. Gastroenterology. 2016 Mar;150(3):591-8. doi: 10.1053/j.gastro.2015.11.037. Epub 2015 Nov 25.
PubMed 26627609
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Evaluating the Impact of NBI on Patients With Barrett's Esophagus Associated Neoplasia Undergoing Endoscopic Eradication Therapy (EET)
- ClinicalTrials.gov ID
- NCT03191604
- Acronym / sponsor ID
- STU00205021
- Conditions
- Barrett Esophagus
- Keywords
- Endoscopy, Narrow band imaging, Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 10 May 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 19 Jun 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 tests the impact of narrow band imaging (NBI) on endoscopists' accurate detection of visible lesions and dysplasia in patients with Barrett's esophagus, as well as the effect of NBI on the choice of primary treatment modality among endoscopists performing endoscopic eradication therapy (EET).
Detailed description
Barrett's esophagus (BE), is a condition whereby normal esophageal squamous epithelium is replaced by metaplastic columnar epithelium, predisposing patients to esophageal adenocarcinoma (EAC). It is estimated that about 5.6% of adults in the United States have BE with risk factors including: long standing gastroesophageal reflux disease, tobacco use, male gender, central obesity, and age over 50 years. EAC is believed to progress in a step-wise pattern with the following order of non-dysplastic BE, low-grade dysplasia (LGD), and high-grade dysplasia (HGD). Each carries a risk of progression to EAC, differing by degree of dysplasia: 0.2-0.5%, 0.7%, and 7% per year, respectively. Given this association, it is common practice to perform endoscopic surveillance with biopsies in patients with BE. Endoscopic surveillance has been shown to detect EAC at earlier stages and improve survival in asymptomatic presentations. As dysplasia in BE may not always be seen as a distinct lesion, surveillance programs entail use of the Seattle Protocol, a systematic four-quadrant biopsy technique obtained at 1 to 2 cm increments. Current guidelines recommend the use of high-definition white light endoscopy (HD-WLE) as it is superior over standard-definition in regards to improved targeted detection of dysplasia.
Advanced endoscopic imaging techniques have been proposed to improve dysplasia detection with preference for electronic chromoendoscopy, specifically narrow band imaging (NBI), as it does not require dye sprays. NBI has been shown to be more accurate in detecting intestinal metaplasia and HGD. HGD is more often detected in areas with subtle mucosal and vascular abnormalities, which may be more difficult to see on HD-WLE alone. However, subtle lesions may go undetected, as NBI is not routinely used in the community with a recent survey showing only about a third of practicing gastroenterologists use advanced endoscopic imaging. The widespread use of NBI has been potentially limited by a perceived complexity of interpretation and lack of standardization. Recently, Sharma et al introduced the BING criteria - a standardized classification system to detect dysplasia and EAC with NBI. While a few studies have demonstrated no significant difference in detection of dysplasia or neoplasia between HD-WLE and NBI, they have had some limitations. The studies occurred prior to the BING classification system, and participants were limited to a few expert tertiary medical centers.
The current standard of care for visible lesions identified by HD-WLE (nodules, ulcers, erosions, or plaques) is endoscopic mucosal resection (EMR). Endoscopic recognition and appropriate resection of visible lesions is essential for optimal patient outcomes. Staging EMR is critical as it allows for histopathological "upgrading" or "downgrading" of dysplasia and ultimately is the best tool for identifying and treating early EAC. Despite the importance of EMR for BE-AN, survey data suggests it is underutilized in practice with 39% of academic endoscopists and 13% of community-based endoscopists performing EMR. While many endoscopists utilize NBI to assist in identification of visible lesions, the resection of areas deemed "abnormal" by NBI alone is not widely accepted. Moreover, endoscopists at community hospitals detect neoplastic lesions at significantly lower rates than at BE expert centers.
Given these data, routine use of NBI prior to EET could significantly impact treatment decisions among all endoscopists with highly accurate rates of dysplasia detection. It's been shown that NBI increases the accuracy and positive predictive value of predicting histology than if HD-WLE is used alone. This study is limited by the use of still-images, which does not accurately reproduce live images seen during endoscopy. Nevertheless, the current standard of using HD-WLE for identification of visible lesions likely underestimates the presence of dysplastic areas in patients undergoing Endoscopic Eradication Therapy (EET) for BE-AN. We hypothesize that the routine use of narrow band imaging (NBI) for identification of visible lesions will improve dysplasia detection and have a significant effect on the choice of primary treatment modality among endoscopists performing EET. To this end, we propose a video-based study to evaluate the impact of NBI on choice of treatment modality during EET.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopists familiar with EET | – | Other: Video interventionPhysicians familiar with conducting endoscopic eradication therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Endoscopist sub-groups include academic endoscopists performing greater than 50 EET procedures per year, community endoscopists performing greater than 50 EET procedures per year, 25 academic gastroenterologists performing greater than 500 upper endoscopies per year not including EET, and 25 community gastroenterologists performing greater than 500 upper endoscopies per year not including EET.
Key inclusion criteria (1 listed)
- Endoscopists familiar with EET.
Key exclusion criteria (2 listed)
- Endoscopists not familiar with EET or non-endoscopists.
- Special populations will not be included in this study.
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 |
|---|---|---|
| Video interventionVideo clips of endoscopy footage with just HD-WLE and clips with NBI will be shown to endoscopists. | Other | Endoscopists familiar with EET |
Primary outcome
Altered chosen treatment modality due to NBI
Time frame: 1 year
Percentage of cases in which use of NBI altered decision-making in regards to initial treatment modality for patients undergoing EET.
3 secondary outcomes
% visable dysplastic lesions detected
Time frame: 1 year
Accurate pathology assessment
Time frame: 1 year
Differences in pathology identification between subgroups
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 4 Nov 2019.
- Background: PubMed 25162890Spechler SJ, Souza RF. Barrett's esophagus. N Engl J Med. 2014 Aug 28;371(9):836-45. doi: 10.1056/NEJMra1314704. No abstract available.
- Background: PubMed 20353441Hayeck TJ, Kong CY, Spechler SJ, Gazelle GS, Hur C. The prevalence of Barrett's esophagus in the US: estimates from a simulation model confirmed by SEER data. Dis Esophagus. 2010 Aug;23(6):451-7. doi: 10.1111/j.1442-2050.2010.01054.x. Epub 2010 Mar 26.
- Background: PubMed 26847374Ireland CJ, Thompson SK, Laws TA, Esterman A. Risk factors for Barrett's esophagus: a scoping review. Cancer Causes Control. 2016 Mar;27(3):301-23. doi: 10.1007/s10552-015-0710-5. Epub 2016 Feb 5.
- Background: PubMed 26526079Shaheen NJ, Falk GW, Iyer PG, Gerson LB; American College of Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol. 2016 Jan;111(1):30-50; quiz 51. doi: 10.1038/ajg.2015.322. Epub 2015 Nov 3.
- Background: PubMed 11967675Incarbone R, Bonavina L, Saino G, Bona D, Peracchia A. Outcome of esophageal adenocarcinoma detected during endoscopic biopsy surveillance for Barrett's esophagus. Surg Endosc. 2002 Feb;16(2):263-6. doi: 10.1007/s00464-001-8161-3. Epub 2001 Nov 16.
- Background: PubMed 11986015Ferguson MK, Durkin A. Long-term survival after esophagectomy for Barrett's adenocarcinoma in endoscopically surveyed and nonsurveyed patients. J Gastrointest Surg. 2002 Jan-Feb;6(1):29-35; discussion 36. doi: 10.1016/s1091-255x(01)00052-x.
- Background: PubMed 15286961Fountoulakis A, Zafirellis KD, Dolan K, Dexter SP, Martin IG, Sue-Ling HM. Effect of surveillance of Barrett's oesophagus on the clinical outcome of oesophageal cancer. Br J Surg. 2004 Aug;91(8):997-1003. doi: 10.1002/bjs.4591.
- Background: PubMed 10189847van Sandick JW, van Lanschot JJ, Kuiken BW, Tytgat GN, Offerhaus GJ, Obertop H. Impact of endoscopic biopsy surveillance of Barrett's oesophagus on pathological stage and clinical outcome of Barrett's carcinoma. Gut. 1998 Aug;43(2):216-22. doi: 10.1136/gut.43.2.216.
- Background: PubMed 11575441Fitzgerald RC, Saeed IT, Khoo D, Farthing MJ, Burnham WR. Rigorous surveillance protocol increases detection of curable cancers associated with Barrett's esophagus. Dig Dis Sci. 2001 Sep;46(9):1892-8. doi: 10.1023/a:1010678913481.
- Background: PubMed 18371135Abela JE, Going JJ, Mackenzie JF, McKernan M, O'Mahoney S, Stuart RC. Systematic four-quadrant biopsy detects Barrett's dysplasia in more patients than nonsystematic biopsy. Am J Gastroenterol. 2008 Apr;103(4):850-5. doi: 10.1111/j.1572-0241.2007.01746.x. Epub 2008 Mar 26.
- Background: PubMed 25209721Sami SS, Subramanian V, Butt WM, Bejkar G, Coleman J, Mannath J, Ragunath K. High definition versus standard definition white light endoscopy for detecting dysplasia in patients with Barrett's esophagus. Dis Esophagus. 2015 Nov-Dec;28(8):742-9. doi: 10.1111/dote.12283. Epub 2014 Sep 10.
- Background: PubMed 24758693Song J, Zhang J, Wang J, Guo X, Yu S, Wang J, Liu Y, Dong W. Meta-analysis of the effects of endoscopy with narrow band imaging in detecting dysplasia in Barrett's esophagus. Dis Esophagus. 2015 Aug-Sep;28(6):560-6. doi: 10.1111/dote.12222. Epub 2014 Apr 24.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Northwestern University 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 1 inclusion and 2 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 4 Nov 2019. 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?
Altered chosen treatment modality due to NBI (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 NCT03191604, which also lists 18 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 4 Nov 2019.