Endoscopic Fluid Collection for Small Intestinal Conditions

Overseen By Christine Chang, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool designed to collect fluid from the small intestine more cleanly and quickly. Inspired by how plants draw water, the tool aims to collect more fluid faster than the usual method. Participants are individuals already scheduled for an endoscopy, a procedure that examines the digestive tract. The trial will compare the new tool, the Capillary Endoscopy Aspiration Catheter, to the existing one by measuring fluid volume collected and collection time. This research could improve how doctors study bacteria in the small intestine. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications since the study involves patients already undergoing a medical procedure.

What prior data suggests that this endoscopic fluid collection method is safe?

Research shows that endoscopic procedures, including those using aspiration catheters, are generally well-tolerated. Although specific safety data for the Capillary Endoscopy Aspiration Catheter is not yet available, the traditional version has been widely used and is considered safe for collecting fluids from the small intestine.

This trial involves a new capillary version of the catheter, currently in an early testing phase called "Not Applicable." This phase focuses on efficacy rather than safety alone. While safety is still being confirmed, the similarity to the traditional catheter provides some reassurance.

Overall, these procedures usually carry a low risk of serious side effects. Prospective participants might find these points reassuring regarding the safety of the new catheter being tested. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the endoscopic fluid collection methods being tested because they offer a new way to collect samples from the small intestine. Unlike traditional methods that might require more invasive procedures, the Capillary Endoscopy Aspiration Catheter and the Endoscopy Aspiration Catheter allow for less invasive sampling directly from the intestinal lining. This could potentially lead to quicker, more accurate diagnoses of small intestinal conditions while reducing patient discomfort and recovery time. By refining these techniques, researchers hope to improve diagnostic precision and overall patient experience.

What evidence suggests that this capillary aspiration catheter is effective for small intestinal fluid collection?

Research has shown that the capillary endoscopy aspiration catheter can simplify sample collection from the small intestine. In this trial, participants in the Capillary Aspiration Endoscopy Catheter group will use this catheter. A study found that it might save between 1 and 6 minutes during an endoscopy by speeding up and improving fluid collection. This suggests it could be quicker and more efficient than standard methods. The tool mimics how plants draw water but improves upon current tools. This innovation could offer a promising option for better assessing bacteria in the small intestine. ^{1 6 7 8 9}

Who Is on the Research Team?

Ali Rezaie, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-85 who are already scheduled to undergo an esophagogastroduodenoscopy, a type of endoscopic examination. There are no specific exclusion criteria since the procedure is being done for medical reasons unrelated to the study.

Exclusion Criteria

There are no exclusion criteria for this study as subjects will be undergoing the procedures for medical reasons and not for the purposes of this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo endoscopy using either a standard or capillary aspiration catheter to collect fluid samples from the small intestine

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events such as perforation and bleeding after the endoscopy procedure

30 minutes

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Capillary Endoscopy Aspiration Catheter
• Endoscopy Aspiration Catheter

Trial Overview The study tests a new capillary endoscopy aspiration catheter against the standard one during endoscopies at Cedars Sinai Medical Center. It aims to compare how well and quickly each catheter can collect fluid from the small intestine in two groups of 23 patients.

How Is the Trial Designed?

Group I: Capillary Aspiration Endoscopy Catheter group Experimental Treatment 1 Intervention

Small intestine aspirate suction was carried out with a capillary aspiration endoscopy catheter

Group II: Aspiration endoscopy catheter group Active Control 1 Intervention

Small intestine aspirate suction was carried out with an aspiration endoscopy catheter

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

Capsule endoscopy (CE) is a safe and non-invasive method that allows for thorough examination of the small intestine, making it well-accepted by patients.

Since its introduction in 2000, CE has become the gold standard for diagnosing various small bowel diseases, including obscure gastrointestinal bleeding and Crohn's disease, and is now also being applied to esophageal and colonic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capsule endoscopy. Muñoz-Navas, M.[2021]

Three new scales for grading small-bowel cleansing during capsule endoscopy (CE) were validated in a study involving 40 patients, showing moderate to substantial reliability for intraobserver assessments, particularly for the quantitative index (QI).

The study found that the distal small bowel had poorer cleansing compared to the entire small bowel, highlighting the importance of evaluating small-bowel cleansing in CE reports to ensure quality assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A validation study of 3 grading systems to evaluate small-bowel cleansing for wireless capsule endoscopy: a quantitative index, a qualitative evaluation, and an overall adequacy assessment. Brotz, C., Nandi, N., Conn, M., et al.[2022]

Small bowel capsule endoscopy (CE) has become the primary diagnostic tool for various small bowel diseases, including obscure gastrointestinal bleeding and Crohn's disease, due to its high diagnostic yield and safety profile.

The future of CE includes advancements such as therapeutic capabilities, improved visualization techniques, and biopsy sampling, which could enhance its effectiveness and broaden its applications in gastrointestinal diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current status and future perspectives of capsule endoscopy. Song, HJ., Shim, KN.[2020]

In a study of 5428 capsule endoscopy procedures, the overall incidence of adverse events (AEs) was low at 1.9%, with the most common issue being capsule retention in the small bowel, particularly in patients with inflammatory bowel disease.

Most patients experiencing AEs had mild or no symptoms, and 64.4% were successfully managed with non-surgical methods, indicating that while AEs can occur, they are generally manageable and not severe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. Fernández-Urién, I., Carretero, C., González, B., et al.[2022]

An endoscopy nurse, after adequate training, can effectively identify significant images in capsule endoscopy studies, achieving excellent agreement with an endoscopist (mean kappa > 0.85).

This approach can enhance the cost-effectiveness of the procedure by reducing the time required for the endoscopist to finalize reports by approximately 5-10 minutes, without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of abnormal lesions recorded by capsule endoscopy. A prospective study comparing endoscopist's and nurse's accuracy. Bossa, F., Cocomazzi, G., Valvano, MR., et al.[2022]

Capsule endoscopy is an innovative method for diagnosing small intestinal disorders, but it carries a risk of the capsule being accidentally aspirated into the lungs, which can lead to serious complications like respiratory failure.

Prompt recognition of this aspiration risk and immediate bronchoscopic removal of the capsule in affected patients can help prevent severe health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration of capsule endoscope and successful bronchoscopic extraction. Girdhar, A., Usman, F., Bajwa, A.[2012]

In a study of 42 patients with suspected gastrointestinal bleeding, video-capsule endoscopy (CE) successfully detected significant pathological findings in 55% of cases, including conditions like angiodysplasia and ulcers.

CE was found to be safe and effective, guiding further diagnostic and treatment decisions in 33% of the patients, suggesting it could be a key tool in diagnosing occult gastrointestinal bleeding after standard endoscopies are normal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Diagnostic utility of capsule endoscopy in occult gastrointestinal bleeding]. Kraus, K., Hollerbach, S., Pox, C., et al.[2006]

Capsule endoscopy is a safe and effective method for examining the small bowel and colon, but there is a small risk of capsule retention, which can be managed conservatively with good outcomes.

To reduce the risk of capsule retention, careful patient selection and the use of patency capsules or imaging techniques like CT or MR enterography are recommended, although these methods do not completely eliminate the risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of small bowel capsule endoscopy. Rosa, B., Dray, X., Koulaouzidis, A.[2023]

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Gastrointestinal Surgical Emergencies This text offers a practical overview of surgical emergencies of the gastrointestinal system. It draws from diverse surgical practices, patients, resources ...