NCT01088646

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

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

October 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

May 2, 2012

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

7 months

First QC Date

March 15, 2010

Results QC Date

March 27, 2012

Last Update Submit

September 30, 2020

Conditions

Small Bowel DiseaseInflammatory Bowel Disease

Keywords

capsule endoscopysmall bowel diseaseinflammatory bowel diseaseSubjects indicated for EGD endoscopy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System

    The number of capsules that successfully were in the duodenum as indicated by video images

    up to 7 days

Secondary Outcomes (1)

  • Physician's Subjective Assessment of the Ease of Capsule Placement

    7 days

Interventions

PillCam® Express Capsule Endoscopy Delivery SystemDEVICE

The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded. The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free.

Eligibility Criteria

Age2 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 2 years
  • Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel

You may not qualify if:

  • Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
  • Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
  • Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
  • Subject is pregnant
  • Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule
  • Subject has known allergy to conscious sedation medications
  • Subject or legal guardian is not able to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Alabama Digestive Disorders Center, P. C.

Huntsville, Alabama, 35802, United States

Location

Alabama Liver and Digestive Specialists

Montgomery, Alabama, 36116, United States

Location

RANY -Research Associates of New York (NY Gastroenterology Associates)

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Results Point of Contact

Title
Hilla Debby/Director of clinical affairs
Organization
Givenimaging
hila.debby@givenimaging.com
97249097774

Study Officials

  • Jonathan Leighton, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Peter Legnani, MD

    Private Practice New York, New York

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: To evaluate the safety and efficacy of an endoscopic capsule placement device.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2010

First Posted

March 17, 2010

Study Start

October 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 22, 2020

Results First Posted

May 2, 2012

Record last verified: 2020-09

Locations

US(3)