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Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance (NOISE)

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Medtronic

Status

Completed

Conditions

Any Gastric Condition Which Requires Capsule Endoscopy

Treatments

Device: Pillcam endoscopy system

Study type

Interventional

Funder types

Industry

Identifiers

NCT02775708
COVGIRD0477

Details and patient eligibility

About

The purpose of this study is to support development of PillCam Endoscopy System applications.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject's from 18 years of age.
  • Subject is indicated for Capsule Endoscopy procedure.
  • Subject agrees to sign the Informed Consent Form.

Exclusion criteria

  • Female subject is pregnant.
  • Subject is known or is suspected to suffer from intestinal obstruction (symptoms such as severe abdominal pain with accompanying nausea or vomiting).
  • Subject has a pacemaker or other implanted electro-medical device.
  • Subject has any condition, which precludes compliance with study and/or device instructions, such as swallowing problems.
  • Subject suffers from life threatening conditions.
  • Subject is currently participating in another clinical study that may directly or indirectly affect the results of this study

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

53 participants in 1 patient group

capsule endoscopy
Experimental group
Description:
open label arm ; up to 100 subjects indicated for capsule endoscopy (CE) procedure will undergo the CE procedure with the Pillcam endoscopy system
Treatment:
Device: Pillcam endoscopy system

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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