Small Bowel DiseaseRD-300NCT01088646
Evaluation of PillCam® Express Capsule Endoscopy Delivery System
A study testing PillCam® Express Capsule Endoscopy Delivery System in people with Small Bowel Disease and Inflammatory Bowel Disease, run by Medtronic - MITG at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System. Read more about this study
- Who is it for?
- Ages 2 to 85 years
- Conditions the study is for
- Small Bowel Disease, Inflammatory Bowel Disease
- What is being tested?
- PillCam® Express Capsule Endoscopy Delivery System
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2009to May 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 2 years
- Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Alabama Digestive Disorders Center, P. C.
Huntsville, Alabama, 35802
Alabama Liver and Digestive Specialists
Montgomery, Alabama, 36116
RANY -Research Associates of New York (NY Gastroenterology Associates)
New York, New York, 10021
About this study
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
Read the 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
- Conditions
- Small Bowel Disease, Inflammatory Bowel Disease
- Being tested
- PillCam® Express Capsule Endoscopy Delivery System
- Keywords
- capsule endoscopy, small bowel disease, inflammatory bowel disease, Subjects indicated for EGD endoscopy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 7 days
Secondary outcomes (1)
Physician's Subjective Assessment of the Ease of Capsule Placement
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Small Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- To evaluate the safety and efficacy of an endoscopic capsule placement device.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Leighton, MD, Principal investigator, Mayo ClinicPeter Legnani, MD, Principal investigator, Private Practice New York, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01088646
- Sponsor's protocol ID
- RD-300
- Acronym
- RD-300
- Status last verified
- Sep 2020
- First submitted
- 15 Mar 2010
- Last updated
- 22 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PillCam® Express Capsule Endoscopy Delivery System
- ClinicalTrials.gov ID
- NCT01088646
- Acronym / sponsor ID
- RD-300 / RD-300
- Conditions
- Small Bowel Disease, Inflammatory Bowel Disease
- Keywords
- capsule endoscopy, small bowel disease, inflammatory bowel disease, Subjects indicated for EGD endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 17 Mar 2010 (estimated)
- Results
- Posted 2 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Model description
- To evaluate the safety and efficacy of an endoscopic capsule placement device.
Who may qualify
- Ages
- 2 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 2 years
- Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PillCam® Express Capsule Endoscopy Delivery SystemThe 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. | Device | – |
Primary outcome
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
Time frame: up to 7 days
The number of capsules that successfully were in the duodenum as indicated by video images
1 secondary outcome
Physician's Subjective Assessment of the Ease of Capsule Placement
Time frame: 7 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Leighton, MD principal investigator
Mayo Clinic
Peter Legnani, MD principal investigator
Private Practice New York, New York
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam® Express Capsule Endoscopy Delivery System in people with Small Bowel Disease and Inflammatory Bowel Disease, run by Medtronic - MITG at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.