Comparison Between Axial- and Lateral-viewing Capsule Endoscopy in Celiac Disease

Study Purpose

Video capsule endoscopy (VCE) is recommended as the gold standard in small bowel exploration. The efficiency of the axial-viewing (Given, Imaging) has been widely reported. The CapsoCam capsule (Capsovision, California, USA) has four cameras allowing the exploration of the small bowel through 360 degree lateral viewing. Celiac disease is the most common autoimmune enteropathy in Western countries, and is usually associated with a good response to the gluten free diet and an excellent prognosis. However, a minority of patients develop complications of the disease, such as refractory celiac disease, ulcerative jejunoileitis and neoplastic complications such as adenocarcinoma of the small bowel and enteropathy associated T cell lymphoma. In recent years, the detection of small bowel lesions has dramatically improved thank to the availability of capsule endoscopy exploration. The aim of this study was to evaluate detection rate and diagnostic concordance of the axial view capsule and CapsoCam capsules in the same patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Adult patients with celiac disease at high risk of complication (see above for a detailed description)

Exclusion Criteria:

- presence of Pacemaker or Defibrillator - suspected small bowel obstruction - impaired swallowing - pregnancy - presence of contraindications to a capsule endoscopy examination

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03095573
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Luca Elli, MD, PhD
Principal Investigator Affiliation Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Additional Details

The study will involve 25 patients with suspected complicated celiac disease , which for clinical reasons are referred for an evaluation of the small intestine by means of capsule endoscopic in order to screen/identify complications. Furthermore, patients under regular follow-up for a known complication of celiac disease (i.e. refractory celiac disease, ulcerative jejunoileitis) will also be enrolled. Patients reffered to the Center for Prevention and Diagnosis of celiac disease at the research Hospital "Fondazione Cà Granda Ospedale Maggiore Policlinico" in Milan will be prospectively evaluated and consecutively enrolled in the study. In agreement with international Guidelines, the diagnosis of celiac disease will be based on Presence of atrophy in the duodenal biopsy sampling (Marsh-Oberhuber type 3) and positive serology or genetic compatibility (in case of seronegative patients at diagnosis). Patients at high risk of celiac disease complications are defined as

  • - subjects older than 50 years at the time of celiac disease diagnosis - subjects with persistence / recurrence of gastrointestinal symptoms after at least 6 months of gluten-free diet - subjects reporting poor compliance to the gluten-free diet - subjects with alarm signs at diagnosis or during follow-up.
All enrolled patients will undergo examination of the small bowel by means of both endoscopic capsule devices (the axial-view PillCam SB3 and the lateral-view CapsoCam) on the same day at approximately 3 hours interval from one another, according to a protocol already validated in terms of security in other studies. The order of administration of the two different capsules, will be determined by a specific randomization sequence. At the end of the examination, recorded data from the capsules will be acquired according to the following steps:
  • - For the axial-view capsule: removal of the recorder after 10 hours recording and/or after checking that the capsule has reached the cecum.
The patient will also be instructed to retrieve the capsule from the stools in the hours / days following the examination as per standard protocol.
  • - For the lateral-view capsule, the patient will be given a specific kit for its retrieval and conservation.
The recorded data will be downloaded after retrieval of the capsule. The 50 videos will be reviewed by three experts operators (L.E., F.B. G.E.T.), blinded and in randomized order. The operators will evaluate the number of lesions detected by the two different types of capsule system (Primary endpoint) and the mean extension of the lesions detected, expressed as percentage of the total transit time of the capsule in the small intestine (Secondary endpoint)

Contact a Trial Team

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International Sites

Milano, MI, Italy

Status

Recruiting

Address

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milano, MI, 20122

Site Contact

Luca Elli, MD, PhD

lucelli@yahoo.com

+390255033384

Irccs Policlinico San Donato, San Donato Milanese, MI, Italy

Status

Active, not recruiting

Address

Irccs Policlinico San Donato

San Donato Milanese, MI, 20097

Site Contact

+390255033384

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