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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiofrequency ablation | Other | Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 1 year after first RFA session with the HALO ULTRA device |
| Hemoglobin level | 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. | 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 | 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. | At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy
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| Name | Affiliation | Role |
|---|---|---|
| Nirav Thosani, MD MHA | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Hermann Hospital | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D020252 | Gastric Antral Vascular Ectasia |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D016888 | Angiodysplasia |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| ID | Term |
|---|---|
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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