Gastric Antral Vascular EctasiaGAVENCT03525366
Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
An observational study of Gastric Antral Vascular Ectasia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE). Research design: This is a prospective observational study. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Gastric Antral Vascular Ectasia
- What is being tested?
- Radiofrequency ablation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2025
- How long will I take part?
- 1 Year
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy
Who may be able to join
- In-patients
- Patients diagnosed with GAVE
- Patients undergoing radiofrequency ablation with HALO ULTRA device
Who cannot join
- Patients who were not diagnosed with GAVE
- Patients undergoing RFA with HALO ULTRA device for diseases other than GAVE.
- Patients with GAVE receiving other endoscopic therapies like argon plasma coagulation (APC) or radiofrequency ablation (RFA) with devices other than HALO ULTRA
Trial locations and contacts
1 site in 1 country.
About this study
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE).
Research design: This is a prospective observational study. Procedure Used: Radiofrequency Ablation
Risks and potential benefits:
There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to other patients in the future.
Read the detailed description
The purpose of this study is to see how well study device works at treating people with Gastric Antral Vascular Ectasia (GAVE). The device has already been approved by the Food and Drug Administration (FDA) and is a part of standard of care. You have been invited to join this research study because you require diagnostic or therapeutic evaluation of the Gastric Antral Vascular Ectasia by RFA.
This is a single -site study being performed at the University of Texas Health Science Center. The study will enroll a total 1000 patients with GAVE. This study is purely observational and will collect clinical information regarding your GAVE
- Conditions
- Gastric Antral Vascular Ectasia
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Gastric Antral Vascular Ectasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationOther
Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of RFA therapy sessions with the HALO ULTRA device
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Measured: Up to 1 year after first RFA session with the HALO ULTRA device
Hemoglobin level
Measured: Before the first RFA session with HALO ULTRA device.
Hemoglobin level
Hemoglobin level will be assessed at the time the patient achieves resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Measured: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Number of patients who require blood transfusion
Measured: Before the first RFA session with HALO ULTRA device
Number of patients who require blood transfusion
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Measured: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study startAug 2015
- Primary completionDec 2022 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Antral Vascular EctasiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nirav C Thosani, The University of Texas Health Science Center, Houston
- Investigators
- Nirav Thosani, MD MHA, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525366
- Sponsor's protocol ID
- HSC-MS-15-0449
- Acronym
- GAVE
- Status last verified
- Aug 2025
- First submitted
- 4 Jan 2016
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
- ClinicalTrials.gov ID
- NCT03525366
- Acronym / sponsor ID
- GAVE / HSC-MS-15-0449
- Conditions
- Gastric Antral Vascular Ectasia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 May 2018 (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.
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE).
Research design: This is a prospective observational study. Procedure Used: Radiofrequency Ablation
Risks and potential benefits:
There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to other patients in the future.
Detailed description
The purpose of this study is to see how well study device works at treating people with Gastric Antral Vascular Ectasia (GAVE). The device has already been approved by the Food and Drug Administration (FDA) and is a part of standard of care. You have been invited to join this research study because you require diagnostic or therapeutic evaluation of the Gastric Antral Vascular Ectasia by RFA.
This is a single -site study being performed at the University of Texas Health Science Center. The study will enroll a total 1000 patients with GAVE. This study is purely observational and will collect clinical information regarding your GAVE
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy
Key inclusion criteria (3 listed)
- In-patients
- Patients diagnosed with GAVE
- Patients undergoing radiofrequency ablation with HALO ULTRA device
Key exclusion criteria (3 listed)
- Patients who were not diagnosed with GAVE
- Patients undergoing RFA with HALO ULTRA device for diseases other than GAVE.
- Patients with GAVE receiving other endoscopic therapies like argon plasma coagulation (APC) or radiofrequency ablation (RFA) with devices other than HALO ULTRA
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 |
|---|---|---|
| Radiofrequency ablationRadiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston. | Other | – |
Primary outcome
Number of RFA therapy sessions with the HALO ULTRA device
Time frame: Up to 1 year after first RFA session with the HALO ULTRA device
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Hemoglobin level
Time frame: Before the first RFA session with HALO ULTRA device.
Hemoglobin level
Time frame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Hemoglobin level will be assessed at the time the patient achieves resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Number of patients who require blood transfusion
Time frame: Before the first RFA session with HALO ULTRA device
Number of patients who require blood transfusion
Time frame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
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 17 Aug 2025.
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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.
Nirav Thosani, MD MHA principal investigator
The University of Texas Health Science Center, Houston
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 Antral Vascular Ectasia, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 3 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 17 Aug 2025. 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 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?
Number of RFA therapy sessions with the HALO ULTRA device (time frame: Up to 1 year after first RFA session with the HALO ULTRA device). The study lists 5 primary outcomes in all. 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 17 Aug 2025.