OFDI Imaging for Duodenal Inspection

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Inability to swallow, Crohn's, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

108 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum. A total of 24 subjects will be asked to swallow the tethered capsule, while they are awake and unsedated and ask for their feedback. Images will be taken using the OFDI system while the capsule travels from the esophagus into the stomach and into the duodenum.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is OFDI Imaging for Duodenal Inspection safe for humans?

Research on colon capsule endoscopy, a similar technology, shows that procedural adverse events are rare and it is generally well-tolerated by patients. ^{1 2 3 4 5}

How does the OFDI Capsule treatment differ from other treatments for duodenal inspection?

The OFDI Capsule is unique because it uses a special mechanism to identify the duodenum and adjust its frame rate to reduce false negatives, unlike traditional capsule endoscopes. It is also smaller and consumes less power, making it more efficient for duodenal inspection. ^{6 7 8 9 10}

Who Is on the Research Team?

Guillermo Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals over 16 with Celiac disease and healthy volunteers over 18, who can swallow pills and give informed consent. It's not for those with Crohn's, fistulas, strictures smaller than the capsule, or pregnant women.

Inclusion Criteria

I am over 18 years old.

Subject must be able to give informed consent

I am over 16 years old and have Celiac disease.

Exclusion Criteria

I cannot swallow pills or capsules.

I have a history of Crohn's disease affecting my intestines.

I am currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging Session

Participants swallow the OFDI capsule for imaging of the duodenum

30 minutes to 2 hours

1 visit (in-person)

Follow-up

Participants are monitored for feedback on tolerability and image quality is assessed

1 week

What Are the Treatments Tested in This Trial?

Interventions

• OFDI Capsule

Trial Overview The study tests a tethered Optical Frequency Domain Imaging (OFDI) capsule to see if it can comfortably and effectively take pictures of the duodenum as it moves through the esophagus into the stomach.

How Is the Trial Designed?

Group I: OFDI Capsule Imaging Experimental Treatment 1 Intervention

Subject will swallow the OFDI Capsule and imaging will be performed using the OFDI system.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

A large-scale survey of 147,439 computed tomographic colonography (CTC) examinations found a very low risk of adverse events, with colorectal perforations occurring in only 0.014% of cases and no reported deaths.

The risk of colorectal perforation was significantly lower during screening procedures (0.003%) compared to preoperative staging (0.028%), and 81% of perforation cases did not require emergency surgery, indicating that CTC is a safe option for colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. Nagata, K., Takabayashi, K., Yasuda, T., et al.[2022]

In a study of 17,067 CT colonography examinations across 50 centers, only 0.08% of patients experienced potentially serious adverse events, indicating a very low incidence of complications associated with the procedure.

Among the adverse events, there were nine perforations, with a symptomatic perforation rate of just 0.03%, suggesting that while complications can occur, they are rare and often asymptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. Burling, D., Halligan, S., Slater, A., et al.[2016]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Rates of minor adverse events and health resource utilization postcolonoscopy. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Accuracy of capsule colonoscopy in detecting colorectal polyps in a screening population. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Outcomes and Preferences for Colon Capsule Endoscopy and Colonoscopy: A Systematic Review with Meta-Analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Duodenum identification mechanism for capsule endoscopy. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Emerging role of narrow band imaging in duodenum. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Multidetector-row CT duodenography in familial adenomatous polyposis: a pilot study. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Two cameras detect more lesions in the small-bowel than one. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

MDCT of the duodenum: technique and clinical applications. [2016]