Gastric VaricesNCT02037659
Dermabond Treatment for Gastric Variceal Bleeding
An observational study of Gastric Varices, run by Indiana University at 1 site in United States.
Trial summary
The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Varices
- What is being tested?
- DermaBond treatment of Gastric Varices
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Mar 2022
- How long will I take part?
- 36 Months
- 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: Patients treated with DermaBond for gastric varices.
Who may be able to join
- Anyone receiving treatment with DermaBond for treatment gastric varices.
Who cannot join
- No evidence of gastric varices.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Hospital
Indianapolis, Indiana, 46202-5121
About this study
Official title: Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository
The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.
Read the detailed description
Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.
- Conditions
- Gastric Varices
- Being tested
- DermaBond treatment of Gastric Varices
- Medical subject headings
- Esophageal and Gastric Varices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermaBond treatment of Gastric VaricesProcedure or surgery
Also called DermaBond: (cyanoacrylate tissue adhesive).
Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.
| Study group | Role | What they receive |
|---|---|---|
| Gastric Varices treatment | DermaBond (glue) treatment of Gastric Varices. Receives: Procedure: DermaBond treatment of Gastric Varices |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.
Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startDec 2012
- Primary completionMar 2022
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric VaricesStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John DeWitt, Indiana University
- Investigators
- John M. DeWitt, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037659
- Sponsor's protocol ID
- Dermabond
- Status last verified
- Mar 2022
- First submitted
- 14 Jan 2014
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository
- ClinicalTrials.gov ID
- NCT02037659
- Acronym / sponsor ID
- Dermabond
- Conditions
- Gastric Varices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 16 Jan 2014 (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 purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.
Detailed description
Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric Varices treatment | – | Procedure: DermaBond treatment of Gastric VaricesDermaBond (glue) treatment of Gastric Varices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with DermaBond for gastric varices.
Key inclusion criteria (1 listed)
- Anyone receiving treatment with DermaBond for treatment gastric varices.
Key exclusion criteria (2 listed)
- No evidence of gastric varices.
- -
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 |
|---|---|---|
| DermaBond treatment of Gastric VaricesAlso: DermaBond: (cyanoacrylate tissue adhesive).Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices. | Procedure or surgery | Gastric Varices treatment |
Primary outcome
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.
Time frame: 36 months
Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required.
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 29 Mar 2022.
- Individual participant dataSharing planned: No
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Esophageal Varices
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.
John M. DeWitt, MD principal investigator
Indiana University
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 Gastric Varices, run by Indiana 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 29 Mar 2022. 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?
To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. (time frame: 36 months). 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 29 Mar 2022.