GAVE - Gastric Antral Vascular EctasiaGAVE CryoNCT04760873
Cryotherapy for GAVE
A study testing cryotherapy in people with GAVE - Gastric Antral Vascular Ectasia and Bleeding, run by H. Lee Moffitt Cancer Center and Research Institute at 5 sites in United States.
Trial summary
Gastric antral vascular ectasia (GAVE) is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia. 1,2 GAVE is commonly associated with liver disease, kidney disease and autoimmune immune problems, but can also be seen in patients without those problems. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- GAVE - Gastric Antral Vascular Ectasia, Bleeding, Bleeding Gastric
- What is being tested?
- cryotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 14 Oct 2020to 22 Jan 2024
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have GAVE
- Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy
- Patients with signs of GI bleeding defined as hemoglobin drop > 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)
- Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)
- Patients who underwent their last ablation at least 4 weeks prior
- Platelet count > 40,000
- International normalized ratio (INR) < 1.5
- Age > 18 years and < 90 years
Who cannot join
- Age < 18 years OR > 90 years
- Inability to obtain consent
- Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- Platelet count < 40,000
- INR > 1.5
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic Foundation of America
Cleveland, Ohio, 44195
Geisinger Medical Center
Danville, Pennsylvania, 17822
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Columbia University Medical Center-NYPH
New York, New York, 10032
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Gastric Antral Vascular Ectasia Treatment With Balloon Cryotherapy: A Multicenter Prospective Trial
Gastric antral vascular ectasia (GAVE) is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia. 1,2 GAVE is commonly associated with liver disease, kidney disease and autoimmune immune problems, but can also be seen in patients without those problems. 2-4 It is common for GAVE to cause hospitalization of patients and significant blood transfusion requirements. Given these problems, effective treatment of GAVE is needed to reduce these potential problems.
These treatments are performed by a gastroenterologist through a flexible endoscope most often with argon plasma coagulation (APC).5-7 APC is only partially successful at eradicating GAVE and often entails repeated endoscopic procedures. Therapy with APC can also cause ulceration at times resulting in acute bleeding. Cryoablation is an attractive alternative to APC as it should not cause increased blood loss and case reports suggest that ablation may be achieved with limited number of endoscopic sessions. Prior problems with endoscopic cryotherapy include the high flow of gas and risk of perforation.8,9 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon, demonstrating clinical safety and efficacy for GAVE.10 A new balloon cryotherapy spray device was recently developed and does not require venting. In this study we plan to prospectively evaluate the use of balloon cryotherapy to treat GAVE. We predict that the therapeutic response of balloon cryotherapy will be greater than 80% effective at achieving clinical success or the loss of overt bleeding and need for packed red blood cell (PRBC) transfusion at 6 months after treatment.
Read the detailed description
Gastric antral vascular ectasia (GAVE), classically termed "watermelon stomach," is a condition of chronic acute blood loss in the gastrointestinal (GI) tract and can lead to common utilization of packed red blood cell (PRBC) transfusion. This condition occurs in 0.3% of endoscopic studies and 4% of studies performed for chronic or acute blood loss anemia.1,2 GAVE is commonly associated with autoimmune disease in 60% of cases and chronic liver disease in 30% of cases.2-4 Given the association with chronic liver disease, GAVE can be mistaken for other GI pathologies such as portal hypertensive gastropathy (PHG).11,12 Therefore, identification of GAVE is important in the management of this condition.
Historically there have been 1 series highlighting the use of a monopolar probe and heater probe to treat GAVE. As these therapies have a low depth of thermal penetration, these therapies are not commonly utilized for GAVE.13,14 The most commonly implemented endoscopic therapy is argon plasma coagulation (APC). Among the largest studies of APC, the efficacy for treatment of GAVE is variable5,6 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC.7 In addition to APC, radiofrequency ablation (RFA) has also been evaluated in the setting of GAVE, leading to a decrease in the transfusions needed during follow-up.15 Similarly, cryotherapy using a spray catheter has been evaluated for GAVE.8,9 In these studies, the patients did demonstrate endoscopic improvement, lower transfusion requirements, and normalization of their hemoglobin. Despite, these results, the spray cryotherapy device requires the use of a venting tube to prevent complications and carries with it technical limitations that can make ablation difficult. Our study group, which includes University Hospitals, Case Western Reserve, Long Island Jewish Medical Center, Geisinger Medical Center, Columbia University Medical Center and The Cleveland Clinic Foundation of America This group has recently evaluated the first generation balloon cryotherapy device for GAVE, demonstrating efficacy and safety.10 Therefore, in this study we set out to prospectively evaluate the efficacy of a new balloon cryotherapy device for the treatment of GAVE. We predict that balloon cryotherapy will lead to greater than 80% clinical success (need for PRBC transfusion and absent overt bleeding).
- Being tested
- cryotherapy
- Keywords
- GAVE, cryotherapy, bleeding, stomach, gastric, EGD, endoscopy
- Medical subject headings
- Gastric Antral Vascular Ectasia, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryotherapyDevice
cryotherapy is a freeze spray that will be applied to GAVE for bleeding
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy for GAVE | Experimental | Subjects will undergo cryotherapy for GAVE Receives: Device: cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
defined by the absence of PRBC transfusions and clinical evidence of bleeding
Measured: 6 months
Secondary outcomes (5)
Technical success
defined as the ability to treat > 75% of the endoscopic area
Measured: 6 months
Endoscopic success
defined as resolution of > 75% of the visible GAVE endoscopic surface
Measured: 6 months
Mean/total number of PRBC transfused
transfusion of packed red blood cells
Measured: 6 months
Change in hemoglobin
change in the lab test hemoglobin in grams/deciLiter
Measured: 6 months
Technical failure
defined as the need for additional ablative modalities to achieve the primary study outcome
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start14 Oct 2020
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Why it stopped: Principal Investigator has not current plans or ability to mov the Study forward.
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 GAVE - Gastric Antral Vascular EctasiaStudies of the same condition, open and under way.
- 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
- Model description
- Subjects with GAVE will undergo therapy with a cryotherapy device
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Long Island Jewish Medical Center, Geisinger Clinic, Columbia University, University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760873
- Sponsor's protocol ID
- MCC-21904
- Acronym
- GAVE Cryo
- Status last verified
- Dec 2024
- First submitted
- 15 Feb 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Electronic health records database will allow for availability of demographic data and office-based follow-up records. ProVation MD software information will provide details regarding endoscopic parameters and intervention performed. Electronic records gathered for study purposes will only be available to study investigators and will be stored on an encrypted hard drive on a computer. Data will initially be entered with PHI attached so that all information can be obtained. Once all data collection is complete identifiers will be removed and random number assigned to the patients. Paper copies of study consents will be filled out in the endoscopy center and stored in a locked cabinet in the endoscopy center workroom. The door to the workroom with the cabinet is locked after hours and the endoscopy center is locked after hours as well.
Publications
Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112.
PubMed 14722858Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70.
PubMed 6332757Lee FI, Costello F, Flanagan N, Vasudev KS. Diffuse antral vascular ectasia. Gastrointest Endosc. 1984 Apr;30(2):87-90. doi: 10.1016/s0016-5107(84)72326-1. No abstract available.
PubMed 6714608Tobin RW, Hackman RC, Kimmey MB, Durtschi MB, Hayashi A, Malik R, McDonald MF, McDonald GB. Bleeding from gastric antral vascular ectasia in marrow transplant patients. Gastrointest Endosc. 1996 Sep;44(3):223-9. doi: 10.1016/s0016-5107(96)70155-4.
PubMed 8885337Roman S, Saurin JC, Dumortier J, Perreira A, Bernard G, Ponchon T. Tolerance and efficacy of argon plasma coagulation for controlling bleeding in patients with typical and atypical manifestations of watermelon stomach. Endoscopy. 2003 Dec;35(12):1024-8. doi: 10.1055/s-2003-44594.
PubMed 14648415Yusoff I, Brennan F, Ormonde D, Laurence B. Argon plasma coagulation for treatment of watermelon stomach. Endoscopy. 2002 May;34(5):407-10. doi: 10.1055/s-2002-25287.
PubMed 11972274Wahab PJ, Mulder CJ, den Hartog G, Thies JE. Argon plasma coagulation in flexible gastrointestinal endoscopy: pilot experiences. Endoscopy. 1997 Mar;29(3):176-81. doi: 10.1055/s-2007-1004159.
PubMed 9201466Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115.
PubMed 12612530Cho S, Zanati S, Yong E, Cirocco M, Kandel G, Kortan P, May G, Marcon N. Endoscopic cryotherapy for the management of gastric antral vascular ectasia. Gastrointest Endosc. 2008 Nov;68(5):895-902. doi: 10.1016/j.gie.2008.03.1109. Epub 2008 Jul 21.
PubMed 18640673Patel AA, Trindade AJ, Diehl DL, Khara HS, Lee TP, Lee C, Sethi A. Nitrous oxide cryotherapy ablation for refractory gastric antral vascular ectasia. United European Gastroenterol J. 2018 Oct;6(8):1155-1160. doi: 10.1177/2050640618783537. Epub 2018 Jun 12.
PubMed 30288277RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available.
PubMed 13052170Selinger CP, Ang YS. Gastric antral vascular ectasia (GAVE): an update on clinical presentation, pathophysiology and treatment. Digestion. 2008;77(2):131-7. doi: 10.1159/000124339. Epub 2008 Apr 4.
PubMed 18391491Petrini JL Jr, Johnston JH. Heat probe treatment for antral vascular ectasia. Gastrointest Endosc. 1989 Jul-Aug;35(4):324-8. doi: 10.1016/s0016-5107(89)72802-9.
PubMed 2788591Gross SA, Al-Haddad M, Gill KR, Schore AN, Wallace MB. Endoscopic mucosal ablation for the treatment of gastric antral vascular ectasia with the HALO90 system: a pilot study. Gastrointest Endosc. 2008 Feb;67(2):324-7. doi: 10.1016/j.gie.2007.09.020.
PubMed 18226696Yao K. The endoscopic diagnosis of early gastric cancer. Ann Gastroenterol. 2013;26(1):11-22.
PubMed 24714327
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Antral Vascular Ectasia Treatment With Balloon Cryotherapy: A Multicenter Prospective Trial
- ClinicalTrials.gov ID
- NCT04760873
- Acronym / sponsor ID
- GAVE Cryo / MCC-21904
- Keywords
- GAVE, cryotherapy, bleeding, stomach, gastric, EGD, endoscopy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator has not current plans or ability to mov the Study forward.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Long Island Jewish Medical Center, Geisinger Clinic, Columbia University, University Hospitals Cleveland Medical Center
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 18 Feb 2021 (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.
Gastric antral vascular ectasia (GAVE) is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia. 1,2 GAVE is commonly associated with liver disease, kidney disease and autoimmune immune problems, but can also be seen in patients without those problems. 2-4 It is common for GAVE to cause hospitalization of patients and significant blood transfusion requirements. Given these problems, effective treatment of GAVE is needed to reduce these potential problems.
These treatments are performed by a gastroenterologist through a flexible endoscope most often with argon plasma coagulation (APC).5-7 APC is only partially successful at eradicating GAVE and often entails repeated endoscopic procedures. Therapy with APC can also cause ulceration at times resulting in acute bleeding. Cryoablation is an attractive alternative to APC as it should not cause increased blood loss and case reports suggest that ablation may be achieved with limited number of endoscopic sessions. Prior problems with endoscopic cryotherapy include the high flow of gas and risk of perforation.8,9 A recent retrospective investigation by this group has evaluated the first generation cryotherapy balloon, demonstrating clinical safety and efficacy for GAVE.10 A new balloon cryotherapy spray device was recently developed and does not require venting. In this study we plan to prospectively evaluate the use of balloon cryotherapy to treat GAVE. We predict that the therapeutic response of balloon cryotherapy will be greater than 80% effective at achieving clinical success or the loss of overt bleeding and need for packed red blood cell (PRBC) transfusion at 6 months after treatment.
Detailed description
Gastric antral vascular ectasia (GAVE), classically termed "watermelon stomach," is a condition of chronic acute blood loss in the gastrointestinal (GI) tract and can lead to common utilization of packed red blood cell (PRBC) transfusion. This condition occurs in 0.3% of endoscopic studies and 4% of studies performed for chronic or acute blood loss anemia.1,2 GAVE is commonly associated with autoimmune disease in 60% of cases and chronic liver disease in 30% of cases.2-4 Given the association with chronic liver disease, GAVE can be mistaken for other GI pathologies such as portal hypertensive gastropathy (PHG).11,12 Therefore, identification of GAVE is important in the management of this condition.
Historically there have been 1 series highlighting the use of a monopolar probe and heater probe to treat GAVE. As these therapies have a low depth of thermal penetration, these therapies are not commonly utilized for GAVE.13,14 The most commonly implemented endoscopic therapy is argon plasma coagulation (APC). Among the largest studies of APC, the efficacy for treatment of GAVE is variable5,6 Additional outcomes include a reduction in the number of PRBC transfused in patients with GAVE that were treated with APC.7 In addition to APC, radiofrequency ablation (RFA) has also been evaluated in the setting of GAVE, leading to a decrease in the transfusions needed during follow-up.15 Similarly, cryotherapy using a spray catheter has been evaluated for GAVE.8,9 In these studies, the patients did demonstrate endoscopic improvement, lower transfusion requirements, and normalization of their hemoglobin. Despite, these results, the spray cryotherapy device requires the use of a venting tube to prevent complications and carries with it technical limitations that can make ablation difficult. Our study group, which includes University Hospitals, Case Western Reserve, Long Island Jewish Medical Center, Geisinger Medical Center, Columbia University Medical Center and The Cleveland Clinic Foundation of America This group has recently evaluated the first generation balloon cryotherapy device for GAVE, demonstrating efficacy and safety.10 Therefore, in this study we set out to prospectively evaluate the efficacy of a new balloon cryotherapy device for the treatment of GAVE. We predict that balloon cryotherapy will lead to greater than 80% clinical success (need for PRBC transfusion and absent overt bleeding).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with GAVE will undergo therapy with a cryotherapy device
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy for GAVE | Experimental | Device: cryotherapySubjects will undergo cryotherapy for GAVE |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have GAVE
- Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy
- Patients with signs of GI bleeding defined as hemoglobin drop > 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)
- Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)
- Patients who underwent their last ablation at least 4 weeks prior
Key exclusion criteria (5 listed)
- Age < 18 years OR > 90 years
- Inability to obtain consent
- Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- Platelet count < 40,000
- INR > 1.5
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 |
|---|---|---|
| cryotherapycryotherapy is a freeze spray that will be applied to GAVE for bleeding | Device | Cryotherapy for GAVE |
Primary outcome
Clinical success
Time frame: 6 months
defined by the absence of PRBC transfusions and clinical evidence of bleeding
5 secondary outcomes
Technical success
Time frame: 6 months
Endoscopic success
Time frame: 6 months
Mean/total number of PRBC transfused
Time frame: 6 months
Change in hemoglobin
Time frame: 6 months
Technical failure
Time frame: 6 months
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 5 Dec 2024.
- Background: PubMed 14722858Dulai GS, Jensen DM, Kovacs TO, Gralnek IM, Jutabha R. Endoscopic treatment outcomes in watermelon stomach patients with and without portal hypertension. Endoscopy. 2004 Jan;36(1):68-72. doi: 10.1055/s-2004-814112.
- Background: PubMed 6332757Jabbari M, Cherry R, Lough JO, Daly DS, Kinnear DG, Goresky CA. Gastric antral vascular ectasia: the watermelon stomach. Gastroenterology. 1984 Nov;87(5):1165-70.
- Background: PubMed 6714608Lee FI, Costello F, Flanagan N, Vasudev KS. Diffuse antral vascular ectasia. Gastrointest Endosc. 1984 Apr;30(2):87-90. doi: 10.1016/s0016-5107(84)72326-1. No abstract available.
- Background: PubMed 8885337Tobin RW, Hackman RC, Kimmey MB, Durtschi MB, Hayashi A, Malik R, McDonald MF, McDonald GB. Bleeding from gastric antral vascular ectasia in marrow transplant patients. Gastrointest Endosc. 1996 Sep;44(3):223-9. doi: 10.1016/s0016-5107(96)70155-4.
- Background: PubMed 14648415Roman S, Saurin JC, Dumortier J, Perreira A, Bernard G, Ponchon T. Tolerance and efficacy of argon plasma coagulation for controlling bleeding in patients with typical and atypical manifestations of watermelon stomach. Endoscopy. 2003 Dec;35(12):1024-8. doi: 10.1055/s-2003-44594.
- Background: PubMed 11972274Yusoff I, Brennan F, Ormonde D, Laurence B. Argon plasma coagulation for treatment of watermelon stomach. Endoscopy. 2002 May;34(5):407-10. doi: 10.1055/s-2002-25287.
- Background: PubMed 9201466Wahab PJ, Mulder CJ, den Hartog G, Thies JE. Argon plasma coagulation in flexible gastrointestinal endoscopy: pilot experiences. Endoscopy. 1997 Mar;29(3):176-81. doi: 10.1055/s-2007-1004159.
- Background: PubMed 12612530Kantsevoy SV, Cruz-Correa MR, Vaughn CA, Jagannath SB, Pasricha PJ, Kalloo AN. Endoscopic cryotherapy for the treatment of bleeding mucosal vascular lesions of the GI tract: a pilot study. Gastrointest Endosc. 2003 Mar;57(3):403-6. doi: 10.1067/mge.2003.115.
- Background: PubMed 18640673Cho S, Zanati S, Yong E, Cirocco M, Kandel G, Kortan P, May G, Marcon N. Endoscopic cryotherapy for the management of gastric antral vascular ectasia. Gastrointest Endosc. 2008 Nov;68(5):895-902. doi: 10.1016/j.gie.2008.03.1109. Epub 2008 Jul 21.
- Background: PubMed 30288277Patel AA, Trindade AJ, Diehl DL, Khara HS, Lee TP, Lee C, Sethi A. Nitrous oxide cryotherapy ablation for refractory gastric antral vascular ectasia. United European Gastroenterol J. 2018 Oct;6(8):1155-1160. doi: 10.1177/2050640618783537. Epub 2018 Jun 12.
- Background: PubMed 13052170RIDER JA, KLOTZ AP, KIRSNER JB. Gastritis with veno-capillary ectasia as a source of massive gastric hemorrhage. Gastroenterology. 1953 May;24(1):118-23. No abstract available.
- Background: PubMed 18391491Selinger CP, Ang YS. Gastric antral vascular ectasia (GAVE): an update on clinical presentation, pathophysiology and treatment. Digestion. 2008;77(2):131-7. doi: 10.1159/000124339. Epub 2008 Apr 4.
- Individual participant dataSharing planned: Yes. Electronic health records database will allow for availability of demographic data and office-based follow-up records. ProVation MD software information will provide details regarding endoscopic parameters and intervention performed. Electronic records gathered for study purposes will only be available to study investigators and will be stored on an encrypted hard drive on a computer. Data will initially be entered with PHI attached so that all information can be obtained. Once all data collection is complete identifiers will be removed and random number assigned to the patients. Paper copies of study consents will be filled out in the endoscopy center and stored in a locked cabinet in the endoscopy center workroom. The door to the workroom with the cabinet is locked after hours and the endoscopy center is locked after hours as well.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryotherapy in people with GAVE - Gastric Antral Vascular Ectasia and Bleeding, run by H. Lee Moffitt Cancer Center and Research Institute at 5 sites 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 8 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 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Clinical success (time frame: 6 months). 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 NCT04760873, 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 5 Dec 2024.