Colonic Polyps
Conditions
Keywords
Colonic Polyps, OCT, Imaging, Colon, Polyp
Brief summary
The goal of this research is to conduct a pilot clinical study to image colonic polyps with the intent to evaluate the potential use of Optical Frequency Domain Imaging (OFDI) to identify the extent of invasion (if present), differentiate between hyperplastic polyps and adenomas, and identify serrated polyps.
Detailed description
The colon OFDI catheter will be used in conjunction with a sigmoidoscope. If a sigmoid polyp is identified, the colonoscope will be removed and a sigmoidoscope inserted. The colon OFDI catheter will be advanced through the sigmoidoscope accessory port and positioned adjacent to the colon wall. Imaging will be performed with the OFDI system across the polyp's surface and the base/stalk if pedunculated. The investigators anticipate that on average the investigators will utilize 4 helical scans per polyp. Each of the scans will take less than 30 seconds.
Interventions
DEVICEMGH Optical Frequency Domain Imaging (OFDI) System
Imaging of Colonic Polyps with OFDI system
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients undergoing a screening colonoscopy * Patients must be over the age of 18 * Patient must be able to give informed consent
Exclusion criteria
* Patients with hemostasis disorders * Patients taking any anti-coagulants such as Coumadin or Plavix,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Sensitivity of OFDI Imaging in the Colon | During the OFDI imaging session which should take an average of 5 mintues | OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OFDI Imaging OFDI imaging
MGH Optical Frequency Domain Imaging (OFDI) System: Imaging of Colonic Polyps with OFDI system | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | OFDI Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
Feasibility and Sensitivity of OFDI Imaging in the Colon
OFDI Images are analyzed and compared to standard of care biopsies in order to differentiate hyperplastic polyps from adenomas or to identify serrated polyps. A total of 15 subjects were consented, but upon inspection of the colon only 2 participants met the eligibility criteria and participated.
Time frame: During the OFDI imaging session which should take an average of 5 mintues
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Feasibility & Sensitivity of OFDI Imaging in the Colon | Feasibility and Sensitivity of OFDI Imaging in the Colon | Feasibility | 2 Participants |
| Feasibility & Sensitivity of OFDI Imaging in the Colon | Feasibility and Sensitivity of OFDI Imaging in the Colon | Sensitivity | 1 Participants |