Gastrointestinal MotilityNCT01158989
Clinical Evaluation Gastrointestinal Motility With PillCam
An observational study of Gastrointestinal Motility, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their overall physical health. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Motility
- What is being tested?
- PillCam
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients (i.e., all were intubated, mechanically ventilated and sedated) and healthy patients scheduled for an outpatient procedure.
Who may be able to join
- mild-to-moderate brain injury patients who suffered from traumatic or non-traumatic intracranial hemorrhage
- admitted to an intensive care unit (ICU)
- needed an enteral tube placed for feeding
- control (ambulatory) group consisted of outpatients with no history of major abdominal surgery
Who cannot join
- younger than 18 years
- suffered multiple injuries (especially abdominal trauma or inflammatory bowel disease)
- had a history of complicated or unknown abdominal surgery
- presented with clinical evidence of ileus or suspected obstruction
- Patients with a pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville Hospital
Louisville, Kentucky, 40202
About this study
Official title: Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients
The purpose of this study is to evaluate the clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their overall physical health. Therefore, the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery. The same device will be used in healthy subjects scheduled for elective ambulatory surgery.
- Conditions
- Gastrointestinal Motility
- Being tested
- PillCam
- Keywords
- Critical care, Endoscopy, Video Capsule, Nutrition, Enteral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCamDevice
Also called PillCam video telemetry capsule, Given Imaging Ltd.
Within four days of hospital admission, qualifying critically ill patients were assigned to the study and received a gastro-jejunal tube and one PillCam video telemetry capsule (Given Imaging Ltd., Yoqneam, Israel). In each critical care patient, placement of the video capsule was coupled with the placement of the medically necessary feeding tube. A flexible endoscope was inserted into the patient's mouth, and then advanced into the esophagus, stomach, and upper small intestine. The capsule was placed into a capsule delivery device and released into the distal duodenum after it had passed beyond the sight of the scope; a wire was placed to facilitate passage of the feeding tube. An abdominal X-ray was obtained to confirm feeding tube tip placement.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill | Critically ill subjects were intubated, mechanically ventilated and sedated Receives: Device: PillCam | |
| Ambulatory Group | Subjects were scheduled for an outpatient procedure but were otherwise healthy Receives: Device: PillCam |
What is being measured
The primary outcome is the main question the study is designed to answer.
small bowel transit times
Small bowel transit time was calculated by measuring the difference between the start-time (i.e., placement of the capsule in the duodenum) and end-time (i.e., capsule enters the cecum). Examination of the differences between subsequent images indicates the amount of capsule movement and is proportional to the instant velocity ("motility") of the capsule
Measured: 8 hours
Secondary outcomes (1)
visualization
The quality of the visualization was determined using a three-step scale: Grade 0: intraluminal fluid disturbed visualization and significantly impaired interpretation: grade 1: intraluminal fluid present but did not impair visualization or interpretation; grade 2: no intraluminal fluid, excellent visualization
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startMay 2006
- Primary completionNov 2007
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal MotilityStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Rauch, MD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158989
- Sponsor's protocol ID
- PillCam
- Status last verified
- Apr 2017
- First submitted
- 6 Jul 2010
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Endoscopic Video Capsule for Investigation of Small Intestine Transit Time and Intestinal Pathology in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01158989
- Acronym / sponsor ID
- PillCam
- Conditions
- Gastrointestinal Motility
- Keywords
- Critical care, Endoscopy, Video Capsule, Nutrition, Enteral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- May 2006
- Primary completion
- Nov 2007 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
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 clinical usefulness of a video camera pill (PillCam) in assessing intestinal function in the small intestines of patients. It is believed that the condition of the subjects digestive system can have a large impact on their overall physical health. Therefore, the investigators would like to assess whether using the pill device helps to determine any functional problems in patients in the ICU. The investigators are studying ICU patients because any change in their condition can have a large impact on their recovery. The same device will be used in healthy subjects scheduled for elective ambulatory surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Critically ill | – | Device: PillCamCritically ill subjects were intubated, mechanically ventilated and sedated |
| Ambulatory Group | – | Device: PillCamSubjects were scheduled for an outpatient procedure but were otherwise healthy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients (i.e., all were intubated, mechanically ventilated and sedated) and healthy patients scheduled for an outpatient procedure.
Key inclusion criteria (4 listed)
- mild-to-moderate brain injury patients who suffered from traumatic or non-traumatic intracranial hemorrhage
- admitted to an intensive care unit (ICU)
- needed an enteral tube placed for feeding
- control (ambulatory) group consisted of outpatients with no history of major abdominal surgery
Key exclusion criteria (5 listed)
- younger than 18 years
- suffered multiple injuries (especially abdominal trauma or inflammatory bowel disease)
- had a history of complicated or unknown abdominal surgery
- presented with clinical evidence of ileus or suspected obstruction
- Patients with a pacemaker
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 |
|---|---|---|
| PillCamAlso: PillCam video telemetry capsule, Given Imaging Ltd.Within four days of hospital admission, qualifying critically ill patients were assigned to the study and received a gastro-jejunal tube and one PillCam video telemetry capsule (Given Imaging Ltd., Yoqneam, Israel). In each critical care patient, placement of the video capsule was coupled with the placement of the medically necessary feeding tube. A flexible endoscope was inserted into the patient's mouth, and then advanced into the esophagus, stomach, and upper small intestine. The capsule was placed into a capsule delivery device and released into the distal duodenum after it had passed beyond the sight of the scope; a wire was placed to facilitate passage of the feeding tube. An abdominal X-ray was obtained to confirm feeding tube tip placement. | Device | Ambulatory Group, Critically ill |
Primary outcome
small bowel transit times
Time frame: 8 hours
Small bowel transit time was calculated by measuring the difference between the start-time (i.e., placement of the capsule in the duodenum) and end-time (i.e., capsule enters the cecum). Examination of the differences between subsequent images indicates the amount of capsule movement and is proportional to the instant velocity ("motility") of the capsule
1 secondary outcome
visualization
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
Stefan Rauch, MD principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Motility, run by University of Louisville at 1 site 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 4 inclusion and 5 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
small bowel transit times (time frame: 8 hours). 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 13 Apr 2017.