NCT03095573

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

March 20, 2017

Last Update Submit

March 29, 2017

Conditions

Celiac Disease

Keywords

Celiac diseaseEnteropathy associated T cell lymphomaRefractory celiac diseaseSmall bowel adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Lesions detected

    Mean number of lesions detected by the two different types of devices, expressed as diagnostic yield and total number of lesions

    up to 24 hours, the time of progression of the capsule through the small bowel

Secondary Outcomes (1)

  • Extension of the lesions

    up to 24 hours, the time of progression of the capsule through the small bowel

Study Arms (2)

Lateral-viewing capsule

EXPERIMENTAL

Examination of the small bowel by means of the lateral-viewing CapsoCam device

Device: Lateral-viewing CapsoCam device

Axial-viewing capsule

ACTIVE COMPARATOR

Examination of the small bowel by means of the axial-viewing capsule

Device: Axial-viewing capsule

Interventions

Lateral-viewing CapsoCam deviceDEVICE

Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device

Lateral-viewing capsule
Axial-viewing capsuleDEVICE

Small bowel capsule endoscopy examination with the Axial-viewing capsule device

Axial-viewing capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, MI, 20122, Italy

RECRUITING

Irccs Policlinico San Donato

San Donato Milanese, MI, 20097, Italy

ACTIVE NOT RECRUITING

Related Publications (11)

  • Volta U, Bellentani S, Bianchi FB, Brandi G, De Franceschi L, Miglioli L, Granito A, Balli F, Tiribelli C. High prevalence of celiac disease in Italian general population. Dig Dis Sci. 2001 Jul;46(7):1500-5. doi: 10.1023/a:1010648122797.

    PMID: 11478502BACKGROUND

  • Green PH, Fleischauer AT, Bhagat G, Goyal R, Jabri B, Neugut AI. Risk of malignancy in patients with celiac disease. Am J Med. 2003 Aug 15;115(3):191-5. doi: 10.1016/s0002-9343(03)00302-4.

    PMID: 12935825BACKGROUND

  • Catassi C, Bearzi I, Holmes GK. Association of celiac disease and intestinal lymphomas and other cancers. Gastroenterology. 2005 Apr;128(4 Suppl 1):S79-86. doi: 10.1053/j.gastro.2005.02.027.

    PMID: 15825131BACKGROUND

  • Culliford A, Daly J, Diamond B, Rubin M, Green PH. The value of wireless capsule endoscopy in patients with complicated celiac disease. Gastrointest Endosc. 2005 Jul;62(1):55-61. doi: 10.1016/s0016-5107(05)01566-x.

    PMID: 15990820BACKGROUND

  • Daum S, Wahnschaffe U, Glasenapp R, Borchert M, Ullrich R, Zeitz M, Faiss S. Capsule endoscopy in refractory celiac disease. Endoscopy. 2007 May;39(5):455-8. doi: 10.1055/s-2007-966239.

    PMID: 17516353BACKGROUND

  • Rondonotti E, Spada C, Cave D, Pennazio M, Riccioni ME, De Vitis I, Schneider D, Sprujevnik T, Villa F, Langelier J, Arrigoni A, Costamagna G, de Franchis R. Video capsule enteroscopy in the diagnosis of celiac disease: a multicenter study. Am J Gastroenterol. 2007 Aug;102(8):1624-31. doi: 10.1111/j.1572-0241.2007.01238.x. Epub 2007 Apr 24.

    PMID: 17459022BACKGROUND

  • Rostom A, Murray JA, Kagnoff MF. American Gastroenterological Association (AGA) Institute technical review on the diagnosis and management of celiac disease. Gastroenterology. 2006 Dec;131(6):1981-2002. doi: 10.1053/j.gastro.2006.10.004. No abstract available.

    PMID: 17087937BACKGROUND

  • Rondonotti E, Soncini M, Girelli C, Ballardini G, Bianchi G, Brunati S, Centenara L, Cesari P, Cortelezzi C, Curioni S, Gozzini C, Gullotta R, Lazzaroni M, Maino M, Mandelli G, Mantovani N, Morandi E, Pansoni C, Piubello W, Putignano R, Schalling R, Tatarella M, Villa F, Vitagliano P, Russo A, Conte D, Masci E, de Franchis R; AIGO, SIED and SIGE Lombardia. Small bowel capsule endoscopy in clinical practice: a multicenter 7-year survey. Eur J Gastroenterol Hepatol. 2010 Nov;22(11):1380-6. doi: 10.1097/MEG.0b013e3283352ced.

    PMID: 20173646BACKGROUND

  • Bardella MT, Elli L, De Matteis S, Floriani I, Torri V, Piodi L. Autoimmune disorders in patients affected by celiac sprue and inflammatory bowel disease. Ann Med. 2009;41(2):139-43. doi: 10.1080/07853890802378817.

    PMID: 18777226BACKGROUND

  • Leighton JA. The role of endoscopic imaging of the small bowel in clinical practice. Am J Gastroenterol. 2011 Jan;106(1):27-36; quiz 37. doi: 10.1038/ajg.2010.410. Epub 2010 Oct 26.

    PMID: 20978483BACKGROUND

  • Pioche M, Vanbiervliet G, Jacob P, Duburque C, Gincul R, Filoche B, Daudet J, Filippi J, Saurin JC; French Society of Digestive Endoscopy (SFED). Prospective randomized comparison between axial- and lateral-viewing capsule endoscopy systems in patients with obscure digestive bleeding. Endoscopy. 2014 Jun;46(6):479-84. doi: 10.1055/s-0033-1358832. Epub 2013 Nov 27.

    PMID: 24285122BACKGROUND

MeSH Terms

Conditions

Celiac DiseaseEnteropathy-Associated T-Cell Lymphoma

Condition Hierarchy (Ancestors)

Malabsorption SyndromesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Luca Elli, MD, PhD

    Fondazione IRCCS Ca´Granda Ospedale Maggiore Policlinico, Milano, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Elli, MD, PhD

CONTACT

+390255033384lucelli@yahoo.com

Federica Branchi, MD

CONTACT

+390255033384federica.branchi@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The videos will be reviewed by three experts operators blinded about the sequence of capsule examination administration
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: Each 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. The order of administration of the two different capsules will be determined by a specific randomization sequence.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 29, 2017

Study Start

March 1, 2017

Primary Completion

October 31, 2018

Study Completion

February 28, 2019

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

IT(2)