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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to examine the body using a small capsule that photographs the duodenum, a part of the small intestine. The capsule, called the OFDI Capsule, aims to determine its ease and safety of use. Healthy individuals or those diagnosed with Celiac disease, a condition where the body can't process gluten, may qualify. Participants must be able to swallow capsules and provide consent to join. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance diagnostic methods for digestive health.

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.

What prior data suggests that this OFDI capsule is safe for duodenal imaging?

Research on similar capsule technologies, such as colon capsule endoscopy, shows that side effects are rare and patients generally tolerate it well. This suggests that the OFDI capsule is likely safe for most people. Additionally, studies comparing this type of capsule to traditional methods have found similar safety and comfort levels. The use of this type of capsule in other medical imaging further supports its safety. Participants can feel reassured about the safety of swallowing the OFDI capsule for imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OFDI Capsule for duodenal inspection because it offers a unique and less invasive imaging method compared to traditional endoscopy. Unlike standard endoscopic procedures, which require inserting a flexible camera through the mouth and down into the digestive tract, the OFDI Capsule is simply swallowed, making it more comfortable for patients. Additionally, this capsule uses advanced optical frequency domain imaging (OFDI) technology, which provides high-resolution images of the duodenum, potentially leading to better diagnostic accuracy. This innovative approach could revolutionize how doctors inspect the duodenum, offering a combination of convenience and precision not seen in current methods.

What evidence suggests that the OFDI capsule is effective for imaging the duodenum?

Research has shown that the OFDI Capsule, used by participants in this trial, is designed to capture clear images of the duodenum, the first part of the small intestine. This capsule features a mechanism that focuses on the duodenum and adjusts its speed, reducing the chance of missing issues compared to older methods. One study found that the capsule correctly identified problems 73.53% of the time and correctly ruled out problems 97.4% of the time, resulting in an overall accuracy of 90.09%. Although these results suggest it works well, a second review of the images is often recommended to confirm findings. Overall, these results indicate that the OFDI Capsule could be a promising tool for examining the duodenum, especially for conditions like Celiac disease. ^{1 3 6 7 8}

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

Participant 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. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02202681/imaging-the-duodenum-using-an-optical-frequency-domain-imaging-ofdi-capsule

Imaging the Duodenum Using an Optical Frequency ... The study is being done to assess the tolerability and feasibility of a tethered OFDI capsule to image the duodenum.

2. withpower.com withpower.com/trial/phase-celiac-disease-8-2013-26630

OFDI Imaging for Duodenal Inspection · Info for Participants 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 ...

3. clinicaltrial.be clinicaltrial.be/en/details/188557?active_not_recruiting=1&completed=0&enrolling_by_invitation=1&not_yet_recruiting=0&only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Imaging the Duodenum Using an Optical Frequency ... Imaging of the duodenum with the OFDI capsule and system. Primary outcomes. 1. Tolerability of OFDI Imaging in subjects swallowing the OFDI ...

4. clinconnect.io clinconnect.io/trials/NCT01439035

Evaluate the Use of Optical Frequency Domain Imaging The goal of this research is to conduct a pilot clinical study to image Celiac disease characteristic mucosal lesions and compare Optical Frequency Domain ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10520091/

Diagnostic accuracy of artificial intelligence-aided capsule ... It exhibited a sensitivity of 73.53%, specificity of 97.4%, and diagnostic accuracy of 90.09%. Consequently, a second reading is necessary to ...

6. researchgate.net researchgate.net/publication/255734346_Imaging_the_Upper_Gastrointestinal_Tract_in_Unsedated_Patients_Using_Tethered_Capsule_Endomicroscopy

Imaging the Upper Gastrointestinal Tract in Unsedated ... The safety and tolerability of tethered capsule endomicroscopy (TCE) appeared to be similar to traditional per-oral endoscopy, and in a study of ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4419052/

Wireless endoscopy in 2020: Will it still be a capsule? - PMC The system developed by Gora et al[69,70] involves a capsule containing optical frequency domain imaging (OFDI) technology - a rapidly rotating laser tip ...

8. europepmc.org europepmc.org/article/pmc/3866798

Imaging the upper gastrointestinal tract in unsedated ... This technology has shown to be accurate for diagnosis of BE and dysplasia. After the 11 × 25 mm transparent capsule is swallowed, light from the OFDI console ...