Trial · NCT02481219
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
NCT02481219, Not applicable, Completed, Medtronic - MITG; results first posted 2016-07-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure. Trials, record NCT02481219. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02481219
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
- NCT number
- NCT02481219
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 122 participants, actual
- Lead sponsor
- Medtronic - MITG
- Conditions
- Colorectal Cancer Screening
- Interventions
- PillCam® COLON 2 procedure-CONTROL, Senna tablets, PEG, Metoclopramide, Erythromycin, SUPREP oral sulfate solution, Bisacodyl, SUPREP oral sulfate solution with Gastrografin
- First posted
- 2015-06-25
- Last updated
- 2017-03-07
- Results first posted
- 2016-07-11
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Within two weeks of study procedure | The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum). |
| Secondary | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assessed from RAPID video in total and by segment |
| Secondary | Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment |
| Secondary | Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assessed from RAPID video in total and by segment |
| Secondary | Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Will be assesses by applicable case report form (CRF) |
| Secondary | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. | Will be assesses by applicable CRF |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Within two weeks of study procedure | this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon. | percentage of particpants | NUMBER |
| SECONDARY | Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments. | percentage of participants | NUMBER |
| SECONDARY | Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam. | hours | MEDIAN |
| SECONDARY | Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | Per protocol analysis set | percentage of participants | NUMBER |
| SECONDARY | Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE | an expected average of 3 weeks from study procedure | PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters | percentage of participants | NUMBER |
| SECONDARY | Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE | Adverse Events (AE) were collected starting from the screening visit and until 5-9 days following the PillCam procedure day. | Full analysis set | percentage of participants with >1 AE | NUMBER |
Source ClinicalTrials.gov
Results by group92
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen -Control | Overall Excellent cleansing | 6.8 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen-Test | Overall Excellent cleansing | 16.7 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen -Control | Cecum Excellent cleansing | 14.0 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen-Test | Cecum Excellent cleansing | 14.6 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen -Control | Ascending Excellent cleansing | 12.2 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen-Test | Ascending Excellent cleansing | 18.2 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen -Control | Transverse Excellent cleansing | 10.6 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen-Test | Transverse Excellent cleansing | 14.6 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen -Control | Descending Excellent cleansing | 9.5 | percentage of particpants | |
| Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) | Bowel Preparation Regimen-Test | Descending Excellent cleansing | 18.5 | percentage of particpants |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bowel Preparation Regimen -Control | 60 | |
| Overall Study | STARTED | Bowel Preparation Regimen-Test | 62 | |
| Overall Study | COMPLETED | Bowel Preparation Regimen -Control | 58 | |
| Overall Study | COMPLETED | Bowel Preparation Regimen-Test | 61 | |
| Overall Study | NOT COMPLETED | Bowel Preparation Regimen -Control | 2 | |
| Overall Study | NOT COMPLETED | Bowel Preparation Regimen-Test | 1 |
Source ClinicalTrials.gov
Adverse events24
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | abdominal pain | Gastrointestinal disorders | Bowel Preparation Regimen -Control | 2 | 59 | 3 |
| other | abdominal pain | Gastrointestinal disorders | Bowel Preparation Regimen-Test | 1 | 62 | 1 |
| other | Irritation | General disorders | Bowel Preparation Regimen -Control | 0 | 59 | 0 |
| other | Irritation | General disorders | Bowel Preparation Regimen-Test | 2 | 62 | 2 |
| other | Muscle strain | Injury, poisoning and procedural complications | Bowel Preparation Regimen -Control | 0 | 59 | 0 |
| other | Muscle strain | Injury, poisoning and procedural complications | Bowel Preparation Regimen-Test | 1 | 62 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Bowel Preparation Regimen -Control | 0 | 59 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Bowel Preparation Regimen-Test | 1 | 62 | 1 |
| other | Dyspesia | Gastrointestinal disorders | Bowel Preparation Regimen -Control | 0 | 59 | 0 |
| other | Dyspesia | Gastrointestinal disorders | Bowel Preparation Regimen-Test | 1 | 62 | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bowel Preparation Regimen -Control | ||
| Total, all-cause mortality | Bowel Preparation Regimen-Test | ||
| Total, other adverse events | Bowel Preparation Regimen -Control | 2 | 59 |
| Total, other adverse events | Bowel Preparation Regimen-Test | 12 | 62 |
| Total, serious adverse events | Bowel Preparation Regimen -Control | 0 | 59 |
| Total, serious adverse events | Bowel Preparation Regimen-Test | 1 | 62 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bowel Preparation Regimen -Control vs Bowel Preparation Regimen-Test: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02481219
GET https://conductscience.org/api/trials/v1/NCT02481219/results?page=2