Gallbladder PolypNCT02492685
Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps
A study testing Quantitative analysis by using the new developed software program VueBox in people with Gallbladder Polyp, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gallbladder Polyp
- What is being tested?
- Quantitative analysis by using the new developed software program VueBox
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Jun 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
- have a plan to evaluate by EUS
- 19 years of age or older
Who cannot join
- difficult undergo EUS,
- allergy for contrast agent,
- renal failure,
- acute coronary syndrome
- pulmonary hypertension, 6) pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Gastroenterology, Department of Internal Medicine, Yonsei Institute of Gastroenterology, Yonsei University College of Medicine
Seoul, 120-752
About this study
The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.
- Conditions
- Gallbladder Polyp
- Being tested
- Quantitative analysis by using the new developed software program VueBox
- Keywords
- Quantitative analysis, contrast enhanced endoscopic ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative analysis by using the new developed software program VueBoxDevice
After acquiring the EUS image by a regular procedure of EUS and contrast-enhanced with one of the fluoro-gas-containing contrast agents (SonoVue, Bracco, Germany), whole video is recorded on the embedded HDD (hard disk drive) of the US system for later analysis. The videos will be analyzed by using the VueBox software (Bracco Suisse SA, Geneva, Switzerland). After surgical treatment, we will compare the results of quantitative analysis with surgical pathology.
| Study group | Role | What they receive |
|---|---|---|
| Contrast enhanced EUS group | Experimental | Contrast enhanced EUS with quantitative analysis Receives: Device: Quantitative analysis by using the new developed software program VueBox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy between visual assessment and quantificational analysis based on surgical pathology
Measured: 1day
Secondary outcomes (4)
Sensitivity between visual assessment and quantificational analysis based on surgical pathology
Measured: 1 day
Specificity between visual assessment and quantificational analysis based on surgical pathology
Measured: 1 day
PPV between visual assessment and quantificational analysis based on surgical pathology
Measured: 1 day
NPV between visual assessment and quantificational analysis based on surgical pathology
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: The study plan was cancelled because patient registration was delayed for the trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gallbladder PolypStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02492685
- Sponsor's protocol ID
- 1-2015-0033
- Status last verified
- Mar 2019
- First submitted
- 1 Jul 2015
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Wildner D, Pfeifer L, Goertz RS, Bernatik T, Sturm J, Neurath MF, Strobel D. Dynamic contrast-enhanced ultrasound (DCE-US) for the characterization of hepatocellular carcinoma and cholangiocellular carcinoma. Ultraschall Med. 2014 Dec;35(6):522-7. doi: 10.1055/s-0034-1385170. Epub 2014 Sep 9.
PubMed 25202903Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.
PubMed 25792386
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantificational Enhancement Pattern Analysis Using a Novel Software "Vuebox" of Contrast-enhanced Harmonic Endoscopic Ultrasonography for Differential Diagnosis Between Adenomas and Cholesterol Polyps
- ClinicalTrials.gov ID
- NCT02492685
- Acronym / sponsor ID
- 1-2015-0033
- Conditions
- Gallbladder Polyp
- Keywords
- Quantitative analysis, contrast enhanced endoscopic ultrasonography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study plan was cancelled because patient registration was delayed for the trials.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 9 Jul 2015 (estimated)
- 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.
The investigators' study is a prospective study to evaluate the enhancement pattern of contrast-enhanced endoscopic ultrasonography and suggest the criterions for differential diagnosis between gallbladder polyps by using software program of quantitative analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast enhanced EUS group | Experimental | Device: Quantitative analysis by using the new developed software program VueBoxContrast enhanced EUS with quantitative analysis |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patient who will be received the exams to evaluate the polyps for treatment plan of surgical treatment
- have a plan to evaluate by EUS
- 19 years of age or older
Key exclusion criteria (5 listed)
- difficult undergo EUS,
- allergy for contrast agent,
- renal failure,
- acute coronary syndrome
- pulmonary hypertension, 6) pregnancy
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 |
|---|---|---|
| Quantitative analysis by using the new developed software program VueBoxAfter acquiring the EUS image by a regular procedure of EUS and contrast-enhanced with one of the fluoro-gas-containing contrast agents (SonoVue, Bracco, Germany), whole video is recorded on the embedded HDD (hard disk drive) of the US system for later analysis. The videos will be analyzed by using the VueBox software (Bracco Suisse SA, Geneva, Switzerland). After surgical treatment, we will compare the results of quantitative analysis with surgical pathology. | Device | Contrast enhanced EUS group |
Primary outcome
Accuracy between visual assessment and quantificational analysis based on surgical pathology
Time frame: 1day
4 secondary outcomes
Sensitivity between visual assessment and quantificational analysis based on surgical pathology
Time frame: 1 day
Specificity between visual assessment and quantificational analysis based on surgical pathology
Time frame: 1 day
PPV between visual assessment and quantificational analysis based on surgical pathology
Time frame: 1 day
NPV between visual assessment and quantificational analysis based on surgical pathology
Time frame: 1 day
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Background: PubMed 25202903Wildner D, Pfeifer L, Goertz RS, Bernatik T, Sturm J, Neurath MF, Strobel D. Dynamic contrast-enhanced ultrasound (DCE-US) for the characterization of hepatocellular carcinoma and cholangiocellular carcinoma. Ultraschall Med. 2014 Dec;35(6):522-7. doi: 10.1055/s-0034-1385170. Epub 2014 Sep 9.
- Background: PubMed 25792386Saftoiu A, Vilmann P, Dietrich CF, Iglesias-Garcia J, Hocke M, Seicean A, Ignee A, Hassan H, Streba CT, Ioncica AM, Gheonea DI, Ciurea T. Quantitative contrast-enhanced harmonic EUS in differential diagnosis of focal pancreatic masses (with videos). Gastrointest Endosc. 2015 Jul;82(1):59-69. doi: 10.1016/j.gie.2014.11.040. Epub 2015 Mar 16.
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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?
A study testing Quantitative analysis by using the new developed software program VueBox in people with Gallbladder Polyp, run by Yonsei University at 1 site in South Korea.
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: withdrawn, as of the sponsor's last update on 18 Mar 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 South Korea. 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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy between visual assessment and quantificational analysis based on surgical pathology (time frame: 1day). 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 NCT02492685, which also lists 2 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 18 Mar 2019.