RD-300: Evaluation of PillCam® Express Capsule Endoscopy Delivery System

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01088646
• Collaborator: (none)
• Enrollment: 25
• Locations: 3
• Duration (Months): 7
• Patients Per Site: 8.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Small Bowel Disease; Inflammatory Bowel Disease	Device: PillCam® Express Capsule Endoscopy Delivery System	N/A

Detailed Description

Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope.

The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies.

Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section.

This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: To evaluate the safety and efficacy of an endoscopic capsule placement device.To evaluate the safety and efficacy of an endoscopic capsule placement device.
• Masking: Single (Investigator)
• Primary Purpose: Device Feasibility
• Official Title: Evaluation of PillCam® Express Capsule Endoscopy Delivery System
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: May 1, 2010

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System [up to 7 days]

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

Secondary Outcome Measures

1. Physician's Subjective Assessment of the Ease of Capsule Placement [7 days]

   The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 2 years

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

Exclusion criteria:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama Digestive Disorders Center, P. C.	Huntsville	Alabama	United States	35802
2	Alabama Liver and Digestive Specialists	Montgomery	Alabama	United States	36116
3	RANY -Research Associates of New York (NY Gastroenterology Associates)	New York	New York	United States	10021

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Principal Investigator: Jonathan Leighton, MD, Mayo Clinic
• Principal Investigator: Peter Legnani, MD, Private Practice New York, New York

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01088646
• Other Study ID Numbers: RD-300
• First Posted: Mar 17, 2010
• Last Update Posted: Oct 22, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Medtronic - MITG: capsule endoscopy; small bowel disease; inflammatory bowel disease; Subjects indicated for EGD endoscopy
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

Participant Flow

Recruitment Details	3 hospital sites

Arm/Group Title	PillCam Express Capsule Delivery System
Arm/Group Description	PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
Period Title: Overall Study
STARTED	25
COMPLETED	25
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PillCam Express Capsule Delivery System
Arm/Group Description	PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
Overall Participants	25
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	20 80%
>=65 years	5 20%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51 (18.3)
Sex: Female, Male (Count of Participants)
Female	19 76%
Male	6 24%
Region of Enrollment (participants) [Number]
United States	25 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
Description	The number of capsules that successfully were in the duodenum as indicated by video images
Time Frame	up to 7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pillcam Express Capsule Delivery System
Arm/Group Description	The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
Measure Participants	25
Number [participants]	25 100%

2. Secondary Outcome

Title	Physician's Subjective Assessment of the Ease of Capsule Placement
Description	The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions.
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

Physicians completed questionnaires for each of the 25 subjects. The questions were divided to two: physicians assessment A where 'YES' is associated with a smooth procedure (4 questions x 25 subjects = 100 Y/N assessments) and physicians B where 'no' is associated with smooth procedure (6 questions x 25 subjects = 150 Y/N assessment).

Arm/Group Title	PillCam Express Capsule Delivery System
Arm/Group Description	PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
Measure Participants	25
Measure Y/N questions	250
Physician Assessment A	94
Physician Assessment B	126

Adverse Events

Time Frame	Adverse Event information was collected from screening (up to -14 day prior to procedure) through follow up phone contact at 5-10 days after the procedure
Arm/Group Title	PillCam Express Capsule Delivery System
Arm/Group Description	PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
All Cause Mortality
	PillCam Express Capsule Delivery System
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Serious Adverse Events
	PillCam Express Capsule Delivery System
	Affected / at Risk (%)	# Events
Total	0/25 (0%)
Other (Not Including Serious) Adverse Events
	PillCam Express Capsule Delivery System
	Affected / at Risk (%)	# Events
Total	1/25 (4%)
Gastrointestinal disorders
capsule failed to deploy in first attempt	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.