AdventHealth
Orlando, Florida, 32804, United States
Location status: Recruiting
Location contact
Dennis Yang, MD
PRINCIPAL_INVESTIGATOR
Diana Paredes, RN
CONTACT
Petronio Martins, MHA
CONTACT
NCT Number: NCT06476145
Non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (EMR-MM) and endoscopic mucosal resection with thermal margin ablation (EMR-STSC)
Interested in participating?
Request Info18 year and older
All sexes
Observational
Orlando, Florida, 32804, United States
Location status: Recruiting
Dennis Yang, MD
PRINCIPAL_INVESTIGATOR
Diana Paredes, RN
CONTACT
Petronio Martins, MHA
CONTACT
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 - 12 (+/- 6 months)
During Screening Colonoscopy (SC) 1, between 3 -12 post initial procedure. The post-EMR site will be assessed and biopsied for histology to assess for recurrence of adenoma.
Time frame: During procedure visit
Time from submucosal injection to completion of resection, including the time required to treat any intraprocedural adverse event, but not including time on prophylactic endoscopic closure.
Time frame: Index procedure visit
MM procedure time is defined as that required to complete placing cautery marks around the lesion prior to resection. STSC time is defined as that required to complete margin ablation around the entire resection margin.
Time frame: Index procedure, 1 - 3 days post, 30 days.
Severe bleeding (immediate or delayed): defined as the need for hospitalization, transfusion, repeat endoscopy, surgery or interventional radiology. Immediate complication is defined as an event at the time of ESD resection or immediately following colonoscopy (before patient has left the endoscopy unit or during the immediate post-procedural care). A delayed (post-procedure) bleed is defined as an event that occurs after the patient has left the endoscopy unit and within 30 days following the procedure
Time frame: Index procedure, 1 - 3 days post, 30 days.
Defined as complete hole, or full-thickness resection of the muscularis propria (Sidney classification of deep mural injury type IV or V).
Time frame: Index procedure, 1 - 3 days post, 30 days.
Abdominal pain severe enough to warrant emergency room or hospital admission in the presence of fever, leukocytosis, peritoneal inflammation in the absence of frank perforation on CT, and/or required treatment with antibiotics.
Contact information is provided by the study sponsor or research team.
Diana Paredes, RN
CONTACT
Petronio Martins, MHA
CONTACT
AdventHealth
Other
Prospective Randomized Controlled Trial Evaluating Adenoma Recurrence After Endoscopic Mucosal Resection With Margin Marking or Post Treatment With Snare Tip Soft Coagulation
Acronym: ERADICATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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