Status:
COMPLETED
A Comparison of Eleview Versus Hetastarch as Injectate for EMR
Lead Sponsor:
Indiana University
Conditions:
Procedural Bleeding
Delayed Bleeding
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
EMR is a technique used for the removal of flat or sessile neoplasms confined to the superficial layers of the GI tract using a snare. Injection-assisted EMR is commonly used during resections of larg...
Detailed Description
Injectate randomization: Study patients will be randomly assigned to the Eleview or the Hetastarch treatment group in a 1:1 ratio. Randomization will occur at the site using envelopes provided by the...
Eligibility Criteria
Inclusion
- Sex and age: men and women \> 18 years old
- Subjects referred for EMR of polyps of size ≥11 mm
- ASA score 1, 2 or 3.
- Contraception: Women of childbearing potential must have a negative pregnancy test (one is provided as the standard of care) or sign a waiver. Post-menopausal women must have been in that status for at least 1 year (per standard of care).
- Subject is willing and able to participate in the study procedures and to understand and sign the informed consent
Exclusion
- Age: Subjects is under 18 years old
- Consent: Vulnerable subjects including those who are unable to consent
- Pregnancy: Pregnant or breastfeeding women
- ASA score \<3
- Physical findings: Abnormal physical findings that may interfere with the study objectives
- Study participation: Subjects currently participating in another clinical study or previously enrolled in another clinical study in the last 30 days
- Excluded lesions:
- Lesions less than 11 mm in largest dimension
- Lesions involving the muscularis propria (T2 lesions)
- Ulcerated depressed lesions (Paris type III) or pathology proven invasive carcinoma
- Proven malignant disease locally advanced or with metastasis
- Active inflammatory bowel disease lesion, e.g ulcerative colitis, Crohn's disease
- Endoscopic appearance of invasive malignancy
- Previous partial resection or attempted resection of the lesion
- Allergy: Proven or potential allergic reaction to study products or history of anaphylaxis to drugs
- Severe liver disease.
- Known or suspected gastrointestinal obstruction or perforation, active diverticulitis, toxic megacolon,
- Inflammatory bowel disease e.g ulcerative colitis or Crohn's disease
- Hemostasis disorders (eg Von Willebrand disease, factor V Leiden thrombophilia or haemophilia), known clotting disorder (INR\>1.5).
- Subject with any other current serious medical conditions that would increase the risks associated with taking part in the study.
- Patients must be advised to stop anticoagulation medications prior to the procedure per local practice guidelines and should re-start as clinically indicated after the procedure.
Key Trial Info
Start Date :
October 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2019
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03350217
Start Date
October 9 2017
End Date
January 7 2019
Last Update
December 17 2019
Active Locations (1)
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1
Indiana University
Indianapolis, Indiana, United States, 46202