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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01750619
Other study ID # 2011.090
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 2011
Est. completion date December 2024

Study information

Verified date March 2022
Source California Pacific Medical Center Research Institute
Contact Jona C Bernabe
Phone 415-600-1151
Email Calitij@sutterhealth.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To evaluate clinical outcome for patients receiving treatment of suspected premalignant and malignant gastrointestinal lesions at Interventional Endoscopy Services. The primary outcome is curative endoscopic resection. Secondary outcomes include resection technique utilized, rates of en bloc resection and adverse event rates, including infection, bleeding, perforation and death, and one-year survival rates.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients age >18 years that have been referred for endoscopic treatment of GI lesions. Exclusion Criteria: - Patients for whom endoscopic treatment was not performed.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Interventional Endoscopy Services San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical success. Technical success is defined as complete resection confirmed by the endoscopic absence of adenomatous tissue after inspection with high-definition white light and narrow-band imaging. 1 day to 3 months
Secondary Short term recurrence rate Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site Less than 1 year
Secondary Long term recurrence rate Freedom from recurrence on follow-up endoscopy with high definition white light and narrow band imaging and on mucosal biopsies of the endoscopic mucosal resection site Greater than 1 year
Secondary Adverse event rate Adverse events include infection, bleeding, perforation and death. up to 1 month post procedure.
Secondary Endoscopic en bloc resection rate Resection in 1 piece without fragmentation, along or extrinsic to the diathermic markings placed around the perimeter of the lesion before resection, without remnant abnormal tissue visible on HD white-light imaging or NBI Immediate
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