Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
60 participants
INTERVENTIONAL
2007-12-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Cryotherapy
cryotherapy
The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.
A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy.
2
Argon Plasma Coagulation
Argon Plasma Coagulation
As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
Interventions
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cryotherapy
The Polar Wand device (GI Supply, Wayne, PA) is FDA 510(k) approved for endoscopic tissue ablation in the GI tract. It consists of a portable cryogen-containing unit and a single-use flexible cryogen spray catheter, designed for use with CO2 that is supplied in standard 20-lb cylinders. Controlled delivery of the cryogen is achieved by a foot pedal, and the tip of the catheter is maintained at about 1 cm from the mucosa. A cryogenic spray is applied to all vascular lesions until a whitened appearance of the mucosa is achieved within 3-5 seconds. Affected areas will be 'painted' by the spray catheter starting at the pylorus and sweeping proximally.
A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy.
Argon Plasma Coagulation
As per current clinical standard, the APC 300 device (ERBE Inc., Marietta, GA) will be used in this study. Targeted ablation of all vascular ectasias as best possible will be performed in standard fashion using an end-firing probe at a setting of 60 W and 2 L/min argon flow rate.A proton pump inhibitor, at double dose, will be prescribed for 1 month after each APC or cryotherapy session to promote mucosal healing post therapy
Eligibility Criteria
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Inclusion Criteria
2. Able to give informed consent
3. Age \> 18 years
Exclusion Criteria
2. Known coagulopathy (INR \> 2), severe thrombocytopenia (platelet count \< 50,000), or bleeding diathesis
3. Endoscopic treatment of WS within the past month
4. Unable or unwilling to give informed consent.
18 Years
85 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Louis-Michel Wong Kee Song
Principal Investigator
Principal Investigators
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Louis M Wongkeesong, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo CLinic
Rochester, Minnesota, United States
Countries
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Other Identifiers
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2261-05
Identifier Type: -
Identifier Source: org_study_id
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