Trial Outcomes & Findings for Advanced Gastrointestinal Endoscopic Imaging (NCT NCT01034670)

NCT ID: NCT01034670

Last Updated: 2024-06-26

Results Overview

Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

5 years

Results posted on

2024-06-26

Participant Flow

Participant milestones

Participant milestones
Measure
Endoscopy Arm
imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound.
Overall Study
STARTED
3
Overall Study
COMPLETED
3
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Advanced Gastrointestinal Endoscopic Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Endoscopy Arm
n=3 Participants
imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
3 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
Race (NIH/OMB)
White
3 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Detection of mucosa abnormailities as a first step in the goal of detection of neoplasia

Outcome measures

Outcome measures
Measure
Endoscopy Arm
n=3 Participants
imaging performed in conjunction with the regularly scheduled endoscopy during which the newer imaging techniques will be used to detect premalignant conditions. includes wide field fluorescence, microscopy, Raman spectroscopy and/or ultrasound.
Number of Participants With Successful Imaging of the Mucosa
3 Participants

Adverse Events

Endoscopy Arm

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shai Friedland, MD

Stanford University

Phone: (650) 617-2732

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place