Gastric Antral Vascular EctasiaNCT07169799
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
A study testing trūFreeze® Spray Cryotherapy System (STERIS Endoscopy) in people with Gastric Antral Vascular Ectasia, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact of cryotherapy spray treatment for eradication of gastric antral vascular ectasia by measuring the change in hemoglobin levels and transfusion requirements in the first 6 months of cryotherapy treatment compared to the previous 6 months Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Antral Vascular Ectasia
- What is being tested?
- trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Dec 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of antral-predominant GAVE: Endoscopic confirmation of gastric-antral vascular ectasia affecting the antrum, without severe portal-hypertensive gastropathy. Sub-classify as nodular or non-nodular GAVE.
- Age: ≥ 18 years at the time of consent.
- Recent transfusion-dependent anemia
- ≥ 1 packed-RBC transfusion for GAVE-related bleeding within the last 6 months to maintain hemoglobin (Hgb) > 8 g/dL (or > 7 g/dL if no coronary/vascular disease).
- Standard-of-care transfusion thresholds:
- If no coronary artery/vascular disease (CVD): transfuse 2 units when Hgb < 7 g/dL.
Show all 16Show fewer
- If CVD present: transfuse 2 units when Hgb < 8 g/dL.
- After any transfusion, re-check Hgb within 1 week and repeat transfusion per the same criteria as needed.
- Documented transfusion history:
- o Medical records must show indication that each transfusion was for presumed GAVE-related bleeding.
- Treatment status:
- o Either treatment-naïve or ≤ 3 prior endoscopic ablation sessions for GAVE.
- Baseline data availability: Participant records must include endoscopic treatment dates, hemoglobin values, and transfusion data for 6 months prior to enrollment (extension up to 9 months permitted if data unavailable). Required elements:
- total number of transfusions,
- total number of prior endoscopic treatments, and calculated change in hemoglobin from baseline: Δ Hgb = Hgb(T-6 mo) - Hgb(T0) [extendable to Hgb(T-9 mo) if 6-month data are incomplete]
- Capacity to consent: Able and willing to provide written informed consent.
Who cannot join
- Other gastrointestinal pathology
- o Active peptic-ulcer disease, inflammatory bowel disease, severe portal-hypertensive gastropathy, or untreated esophageal/gastric varices.
- Coagulopathy
- o Known bleeding disorder or acquired coagulopathy not attributable to GAVE.
- Severe comorbidity / high procedural risk
- Advanced heart failure, severe renal impairment, or any condition classified ASA IV or V.
Show all 16Show fewer
- Estimated life-expectancy < 6 months.
- Karnofsky performance status ≤ 40.
- Deemed unfit for endoscopic procedures by the treating physician.
- Pregnancy / lactation:
- o Pregnant or breastfeeding, or planning pregnancy within 6 months of consent.
- Prior incompatible therapy
- o Previous cryoballoon ablation for GAVE.
- Ability to participate
- Unable or unwilling to comply with the protocol or follow-up schedule.
- Unable or unwilling to provide written informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kristen Lozano contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Stephanie McNew, B.S., 904-953-0580, mcnew.stephanie@mayo.edu
Swathi Eluri, M.D.
About this study
Official title: Evaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
The purpose of this study is to evaluate the impact of cryotherapy spray treatment for eradication of gastric antral vascular ectasia by measuring the change in hemoglobin levels and transfusion requirements in the first 6 months of cryotherapy treatment compared to the previous 6 months
- Conditions
- Gastric Antral Vascular Ectasia
- Being tested
- trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)
- 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.
trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)Other
Also called Procedure: EGD and truFreeze® spray-cryotherapy
This treatment consists of performing a diagnostic EGD to identify GAVE lesions. A catheter advances through the therapeutic channel to treat target areas with cryotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Prospective arm: Spray Cryotherapy | Other | Subjects to receive baseline endoscopic confirmation/classification of GAVE, laboratory panels, and clinical indices. Once confirmed, subjects will undergo cryotherapy procedure schedule. Receives: Other: trūFreeze® Spray Cryotherapy System (STERIS Endoscopy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.
Changes in mean hemoglobin concentrations.
Total number of packed-RCB units during a 6-month period after treatment and 6-months prior to treatment (retrospective review)
Measured: over 6 month period
Secondary outcomes (1)
Endoscopic success.
Endoscopic success (as assessed by independent endoscopic image review) measured safety of the cryotherapy procedure (adverse event tracking and assessments) change in means of patient's quality of life (measured by SF-12)
Measured: over 6 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start22 Dec 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Mayo ClinicThe 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
- Model description
- Open-label, single-arm pre-post study with a 1:2 matched historical control cohort
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swathi Eluri, Mayo Clinic
- Investigators
- Swathi Eluri, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169799
- Sponsor's protocol ID
- 25-002286
- Status last verified
- Mar 2026
- First submitted
- 5 Sep 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
- ClinicalTrials.gov ID
- NCT07169799
- Acronym / sponsor ID
- 25-002286
- Conditions
- Gastric Antral Vascular Ectasia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Dec 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Sep 2025 (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 of this study is to evaluate the impact of cryotherapy spray treatment for eradication of gastric antral vascular ectasia by measuring the change in hemoglobin levels and transfusion requirements in the first 6 months of cryotherapy treatment compared to the previous 6 months
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label, single-arm pre-post study with a 1:2 matched historical control cohort
| Arm | Type | Receives |
|---|---|---|
| Prospective arm: Spray Cryotherapy | Other | Other: trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)Subjects to receive baseline endoscopic confirmation/classification of GAVE, laboratory panels, and clinical indices. Once confirmed, subjects will undergo cryotherapy procedure schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Diagnosis of antral-predominant GAVE: Endoscopic confirmation of gastric-antral vascular ectasia affecting the antrum, without severe portal-hypertensive gastropathy. Sub-classify as nodular or non-nodular GAVE.
- Age: ≥ 18 years at the time of consent.
- Recent transfusion-dependent anemia
- Documented transfusion history:
- o Medical records must show indication that each transfusion was for presumed GAVE-related bleeding.
Key exclusion criteria (16 listed)
- Other gastrointestinal pathology
- o Active peptic-ulcer disease, inflammatory bowel disease, severe portal-hypertensive gastropathy, or untreated esophageal/gastric varices.
- Coagulopathy
- o Known bleeding disorder or acquired coagulopathy not attributable to GAVE.
- Severe comorbidity / high procedural risk
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 |
|---|---|---|
| trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)Also: Procedure: EGD and truFreeze® spray-cryotherapyThis treatment consists of performing a diagnostic EGD to identify GAVE lesions. A catheter advances through the therapeutic channel to treat target areas with cryotherapy. | Other | Prospective arm: Spray Cryotherapy |
Primary outcome
Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.
Time frame: over 6 month period
Changes in mean hemoglobin concentrations. Total number of packed-RCB units during a 6-month period after treatment and 6-months prior to treatment (retrospective review)
1 secondary outcome
Endoscopic success.
Time frame: over 6 month period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Gastric Antral Vascular Ectasia
RecruitingObservational study
Prevalence of Gastric Motor Dysfunction and Upper GI Symptoms in Gastric Antral Vascular Ectasias
Gastric Antral Vascular Ectasia, Cirrhosis
Enrolling by invitation
Correlations of the Microvascular Abnormalities on NVC (Nail Fold Video Capillaroscopy) and GAVE (Gastric Antral Vascular Ectasia) as Seen on EGD
Gastric Antral Vascular Ectasia
Not yet recruitingObservational study
Study on the Efficacy of Endoscopic Radiofrequency Treatment in Reducing the Need for Blood Transfusions in GAVE
GAVE - Gastric Antral Vascular Ectasia
Not yet recruiting
Thalidomide Versus Argon Plasma Coagulation in Gastric Antral Vascular Ectasia(GAVE)-Related Anaemia in Cirrhosis (TAG Trial)
Liver Cirrhosis, Gastric Antral Vascular Ectasia
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.
Kristen Lozano contact
Swathi Eluri, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing trūFreeze® Spray Cryotherapy System (STERIS Endoscopy) in people with Gastric Antral Vascular Ectasia, run by Mayo Clinic 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 16 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie McNew (904-953-0580, mcnew.stephanie@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia. (time frame: over 6 month period). 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 3 Apr 2026.