Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy

NCT01085513 | Terminated Results

• 1 other identifier: MA-68
• Study Type: interventional
• Target: 143
• Locations: 5 countries
• Sites: 6

Brief Summary

Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility. However intestinal manometry involves intestinal intubation with consequent discomfort for the patients, and requires considerable technical expertise and knowledge for interpretation of the data. Hence, to date this method has limited indications and is restricted to very few referral centers around the world. A novel method for evaluation of intestinal motility has been developed based on endoluminal image analysis using the endoscopic PillCam capsule, In contrast to manometry, this technique is minimally invasive, the technical aspects are simple, and the analysis is fully automated by a computer program. The technique has been validated in a group of patients with intestinal dysmotility and healthy subjects, and has demonstrated over 90% sensitivity and specificity. This technique needs now to be validated in a large multinational population, to further develop a robust discrimination algorithm for widespread diagnostic application. Furthermore, whereas manometry only recognizes neuropathic, myopathic and obstructive motor patterns, endoluminal image analysis may identify different categories of patients depending on the clinical presentation and the etiologic factors involved. This study is designed to provide evidence that the algorithm, using images created by PillCam SB2 capsules, is at least as good as small bowel manometry in diagnosing severe dysmotility.

Conditions

Intestinal Abnormalities

Keywords

intestinal abnormalities

Outcome Measures

Primary Outcomes (1)

• To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility

  Patients were indicated for small bowel manometry based on one or both of the following symptoms: * Pseudo obstruction * Unintentional body weight loss

  Up to 7 months

Secondary Outcomes (1)

• To Assess Correlation Between Patient Clinical Symptoms and CE-EIA

  Up to 7 months

Study Arms (2)

Patients

ACTIVE COMPARATOR

Patients previously indicated for manometry

Device: PillCam SB2

Healthy volunteers

ACTIVE COMPARATOR

Healthy volunteers

Device: PillCam SB2

Interventions

PillCam SB2 DEVICE

The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.

Healthy volunteers; Patients

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's age is 16-80 years, inclusive.
• One of the following SB manometry procedures:
• Underwent SB manometry within five years if results were abnormal
• Underwent SB manometry within 1 year if results were normal
• Scheduled for SB manometry within six months of enrollment date
• Patient was indicated for small bowel manometry based on one or both of the following symptoms:
• Pseudo obstruction of the small bowel: symptoms resembling mechanical small bowel obstruction without evidence of luminal compromise of the gut. Mechanical occlusion is ruled-out by endoscopic and / or radiological studies following the criteria of the attending physician.
• Patients may have any of the following:
• recurrent acute episodes (at least two) with air fluid levels (as evidenced at least once by abdominal X-ray), or
• chronic symptoms with small bowel dilation resembling a partial mechanical obstruction.
• Patients will be tested during period of (non-acute) remission. - Chronic severe GI symptoms with inability to maintain normal body weight: abdominal symptoms (such as nausea, abdominal distension, discomfort or pain) produce inability to maintain a normal body weight as defined by unintentional weight loss of at least 10% of original body weight before onset of symptoms or a BMI \< 18.5, while on a normal diet (without oral dietary supplements, enteral or parenteral feeding).
• These should be chronic symptoms lasting at least 6 months.
• \- Patient or legal guardian agrees to sign consent form

You may not qualify if:

• Acute exacerbation of chronic obstructive symptoms.
• Mechanical obstruction of any kind such as definite long stricture seen on radiological exam.
• Suspected GI stricture, followed by Agile® study that could not prove patency of the GI tract.
• Known history of small bowel organic disease such as Crohn's Disease or Celiac.
• Patient suffers from any condition, such as swallowing problems or having an implanted cardiac pacemaker or defibrillator which precludes compliance with study and/or device instructions.
• Non-steroidal anti-inflammatory drugs including aspirin, (twice weekly or more) during the 4 weeks preceding the CE exam.
• Patient has undergone gastrectomy (segmental small bowel resection over 30%).
• During the period between small bowel manometry and Capsule endoscopy, the patient has undergone any abdominal surgical procedures other than appendectomy, cholecystectomy, abdominal wall hernia repair or catheter placing for enteral feeding.
• Manometry was performed before any other allowed GI procedure.
• Patient is pregnant.
• Known abuse of alcohol or illicit substances.
• Patient presently presenting with an acute life threatening condition.
• Participating in another clinical study within 30 days.
• Volunteer's age is 16-80 years, inclusive.
• Known diabetes mellitus

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (6)

Division of Gastroenterology and Hepatology Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic,

Rochester, Minnesota, 55905, United States

Location

Center for GI Research, KU Leuven,

Leuven, 3000, Belgium

Location

Internal Medicine & Gastroenterology, University of Bologna,

Bologna, I-40138, Italy

Location

Autonomous University of Barcelona

Barcelona, 08035, Spain

Location

Departement of Internal Medicine, Sahlgrenska Universitetss

Gothenburg, 41345, Sweden

Location

Limitations and Caveats

This study terminated early due to slow recruitment. Phase 1 of the study enrolled but was intended to train an algorithm only.The validation phase 2 which supported objectives was not completed and the study objectives could not be evaluated.

Results Point of Contact

• Title: director of clinical affairs
• Organization: Given Imaging

Hila.debby@givenimaging.com

+972-4-9097774

Study Officials

• Fernando Azpiroz, Prof.

  Universitat Autonoma de Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 12, 2010
• Study Start: February 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: July 22, 2020
• Results First Posted: June 23, 2014

Record last verified: 2020-01

Locations

SE (1); ES (1); BE (1); US (2); IT (1)