German Colon Capsule Registry

NCT02182466 | Terminated

• 2 other identifiers: 265/13DRKS-ID: DRKS00006283
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the registry is to evaluate all colon capsule endoscopies performed in Germany. This is to investigate safety, quality assurance and quality control of colon capsule endoscopy.

Conditions

Colon Cancer; Colon Polyp; Diarrhea; Inflammatory Bowel System; Ulcerative Colitis

Keywords

Colon capsule endoscopy; Colonoscopy; Screening colonoscopy

Outcome Measures

Primary Outcomes (1)

• Establishing a diagnosis from colon capsule endoscopy

  Participants will be followed for the time of presentation at the outpatient clinic or for the duration of hospital stay, an expected average of 2 weeks after performance of the investigation

  At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation

Secondary Outcomes (3)

• Technical success of colon capsule endoscopy

  At presentation of the patient for performing colon capsule endoscopy until end of colon capsule endoscopy, an average of 24 hours

• Complications of colon capsule endoscopy, i.e. number of participants with Adverse Events and characterization of Adverse Events

  At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation

• Cleansing level of colon capsule endoscopy

  At presentation of the patient until dismissal from medical care, an expected average of 2 weeks after performance of the investigation

Study Arms (1)

Colonic endoscopy indicated

Device: Colon capsule endoscopy

Interventions

Colon capsule endoscopy DEVICE

Colonic endoscopy indicated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with indication for endoscopic investigation of the colon

You may qualify if:

• Indication for colon capsule endoscopy
• Age of 18 years or older
• Consent of the patient

You may not qualify if:

• Intestinal obstruction
• Dyphagia
• Pregnancy

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Frankfurt University Hospital

Frankfurt am Main, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Diarrhea; Colitis, Ulcerative

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms; Colitis; Gastroenteritis; Inflammatory Bowel Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jörg G Albert, MD

  Frankfurt University Hospital Department of Internal Medicine I Theodor-Stern-Kai 7 D-60590 Frankfurt/Main Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: [Dokumentation von Kolonkapsel-Endoskopien im Rahmen einer bundesweiten Studie]

Study Record Dates

• First Submitted: June 27, 2014
• First Posted: July 8, 2014
• Study Start: June 1, 2014
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

DE (1)