Health TrialsbyHealthPanel

Capillary Endoscopy Aspiration Catheter

ConditionsMicrobiotaSIBO
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCedars-Sinai Medical Center

About this trial

The small intestine is an understudied frontier of microbiome research. While aspiration during endoscopy is considered the gold standard to assess small bowel bacteria, the tools for sterile retrieval are primitive and poorly validated.

Endoscopic aspiration is time-consuming and prone to contamination. Inspired by plants' ability to draw water by capillary action, a novel multi-capillary sterile system was designed which is a modified version of the conventional aspiration catheter.

The purpose of this study is to examine the time and volume capabilities of this catheter in suctioning various liquids compared to conventional aspiration catheter, in two groups, each includes 23 patients that going under endoscopy at GI lab at Cedars Sinai Medical Center. The investigator will collect up to 2 ml fluid from Duodenum- in first group by using the conventional catheter and in second group by using the capillary catheter. The time collection and the volume of samples in 2 groups will be compared.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female subjects aged 18-85 undergoing esophagogastroduodenoscopy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capillary Endoscopy Aspiration Catheter

    Device

    Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter\[#CSL2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy

  • Endoscopy Aspiration Catheter

    Device

    Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter\[#2182; Hobbs Medical,Inc. Connecticut, US\] during upper endoscopy

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Capillary Aspiration Endoscopy Catheter groupExperimental treatment 1 intervention
Group B: Aspiration endoscopy catheter groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The volume(millilitres) of the aspirate that will be suctioned from small intestine in two groups

The volume(millilitres) of the aspirate that collected from small intestine during upper endoscopy will be the primary end point

Time frame
5 minutes
2

The time(minutes) of the aspirate collection from small intestine will be measured in two groups

The time(minutes) of the aspirate collection from small intestine will be measured in two groups

Time frame
5 minutes

Secondary outcomes

1

The rate of adverse events such as perforation, and bleeding in two groups

The rate of adverse events at 30 minutes after endoscopy

Time frame
30 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov
Apply now