Trial Outcomes & Findings for Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease. (NCT NCT03241368)

Last Updated: 2020-06-09

Results Overview

Central readers will be used to read all videos/images and analyses will be based on these results. A consensus panel will be used if there are discrepancies in results between modalities at baseline. Capsule endoscopy and IC results will be read by gastroenterologists and MRE results will be read by radiologists. Scores used will be Lewis Score, Simple Endoscopic Score for Crohn's Disease Index (SES-CD) Score and Magnetic Resonance Index of Activity (MaRIA) Score

Recruitment status

COMPLETED

Study phase

Target enrollment

187 participants

Primary outcome timeframe

Baseline

Results posted on

2020-06-09

Participant Flow

187 subjects signed consent. Per the protocol, a subject was not considered "enrolled" until consent was signed and subject met inclusion/exclusion criteria. Of the 187 who signed consent, 158 were considered "enrolled" per the protocol. 29 were "screen failures", i.e. they signed informed consent, but ended up failing inclusion/exclusion.

Of the 187 subjects who signed informed consent, 29 failed inclusion/exclusion criteria and were exited from the study. Criteria included labs, which caused some subjects to wash out at this early phase. This left us with 158 subjects. For various reasons, 39 additional subjects were exited prior to all imaging procedures being completed.

Participant milestones

Participant milestones
Measure	MRE, Patency Capsule (if Needed), CE, and IC Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency not confirmed by MRE or patency capsule, subject is discontinued from study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final polyethylene glycol (PEG) ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If IC is done the following day, subject will stay on clear liquid diet (or NPO (nothing by mouth), per physician discretion).
Overall Study STARTED	158
Overall Study COMPLETED	119
Overall Study NOT COMPLETED	39

Reasons for withdrawal

Reasons for withdrawal
Measure	MRE, Patency Capsule (if Needed), CE, and IC Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency not confirmed by MRE or patency capsule, subject is discontinued from study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final polyethylene glycol (PEG) ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If IC is done the following day, subject will stay on clear liquid diet (or NPO (nothing by mouth), per physician discretion).
Overall Study MRE Stricture or Patency Capsule Failure	25
Overall Study Lost to Follow-up	1
Overall Study Physician Decision	6
Overall Study Withdrawal by Subject	6
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=99 Participants Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	96 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Sex: Female, Male Female	63 Participants n=99 Participants
Sex: Female, Male Male	36 Participants n=99 Participants
Region of Enrollment Austria	2 participants n=99 Participants
Region of Enrollment United States	95 participants n=99 Participants
Region of Enrollment Israel	2 participants n=99 Participants
BMI	28.82 kg/m² STANDARD_DEVIATION 7.36 • n=99 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Per-protocol analysis set, includes subjects who underwent MRE, CE, and IC (and could be evaluated for CD activity) who had no major deviations (violations that may have significant impact on outcomes) and did not meet following criteria: * Subject withdraws * Capsule remained in stomach or small bowel for entire procedure * Technical failure

Outcome measures

Outcome measures
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=99 Participants Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).
Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. Sensitivity CE Overall	94 percentage of participants Interval 86.0 to 98.0
Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. Sensitivity MRE + IC Overall	100 percentage of participants Interval 95.0 to 100.0
Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. Specificity CE Overall	74 percentage of participants Interval 55.0 to 87.0
Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. Specificity MRE + IC Overall	22 percentage of participants Interval 10.0 to 41.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=99 Participants Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).
Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE. Specificity	74 percentage of participants Interval 55.0 to 87.0
Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE. Negative Predictive Value (NPV)	83 percentage of participants Interval 64.0 to 94.0
Specificity, Negative Predictive Value, and Positive Predictive Value for Active CD in the Small Bowel and Colon by CE as Compared to IC Plus MRE. Positive Predictive Value (PPV)	91 percentage of participants Interval 82.0 to 96.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=99 Participants Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV MRE + IC TI	93 percentage of participants Interval 68.0 to 100.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV CE TI	88 percentage of participants Interval 76.0 to 94.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity CE Proximal Small Bowel (PSB)	97 percentage of participants Interval 82.0 to 100.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV CE PSB	98 percentage of participants Interval 90.0 to 100.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV MRE PSB	83 percentage of participants Interval 71.0 to 91.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV CE PSB	77 percentage of participants Interval 62.0 to 88.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV MRE PSB	49 percentage of participants Interval 35.0 to 63.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity CE Terminal ilium (TI)	94 percentage of participants Interval 84.0 to 99.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity MRE + IC TI	98 percentage of participants Interval 89.0 to 100.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity CE TI	82 percentage of participants Interval 66.0 to 91.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity MRE + IC TI	37 percentage of participants Interval 23.0 to 53.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV CE TI	91 percentage of participants Interval 76.0 to 98.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV MRE + IC TI	68 percentage of participants Interval 57.0 to 78.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity CE Colon	83 percentage of participants Interval 62.0 to 94.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity IC Colon	91 percentage of participants Interval 72.0 to 99.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity CE Colon	88 percentage of participants Interval 77.0 to 94.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity IC Colon	89 percentage of participants Interval 79.0 to 95.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV CE Colon	93 percentage of participants Interval 84.0 to 98.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE NPV IC Colon	97 percentage of participants Interval 88.0 to 100.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV CE Colon	70 percentage of participants Interval 51.0 to 84.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE PPV IC Colon	75 percentage of participants Interval 56.0 to 88.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Sensitivity MRE PSB	71 percentage of participants Interval 53.0 to 84.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity CE PSB	87 percentage of participants Interval 76.0 to 93.0
Sensitivity, Specificity, Negative Predictive Value and Positive Predictive Value for Active CD in Designated Bowel Segments (Proximal Small Bowel Terminal Ileum, and Colon) by Capsule Endoscopy as Compared to IC Plus MRE Specificity MRE PSB	66 percentage of participants Interval 54.0 to 76.0

SECONDARY outcome

Timeframe: After completion of final procedure, either the same day or by the next business day following procedure completion.

Population: Subjects who completed the satisfaction questionnaire and underwent all 3 procedures MRE, CE, and IC and could be evaluated for overall active CD at baseline (i.e., a modified intent-to-treat (mITT). population).

Patient preference of which procedure they preferred (CE, IC or MRE plus IC)

Outcome measures

Outcome measures
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=118 Participants Subjects will undergo MRE, patency capsule (if necessary), CE, and IC procedures. If MRE shows evidence of a stricture, subject must undergo a Patency procedure prior to CE. If patency cannot be confirmed through MRE or patency capsule will be discontinued from the study. Subjects will perform bowel preparation and follow a detailed dietary regimen for CE and IC procedures. Between 45 and 75 minutes after final PEG ingestion, subject will swallow the PillCam Crohn's Capsule. Adequate boosts will be administered, as necessary. Subjects will be allowed to leave clinic after 'Alert 2' is received and if capsule is not yet excreted. Subjects leaving prior to excretion will be instructed to disconnect the recorder at excretion or battery failure (whichever is first). After CE procedure (either same or following day), subject will undergo IC. If the IC is done the following day, subject will stay on clear liquid diet (or NPO, per physician's discretion for sedation).
Patient Satisfaction Preferred PillCam CE	64 Participants
Patient Satisfaction Preferred IC	43 Participants
Patient Satisfaction Preferred MRE + IC	11 Participants

Adverse Events

MRE, Patency Capsule (if Needed), CE, and IC

Serious events: 7 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=119 participants at risk Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure. Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure
Gastrointestinal disorders Abdominal pain	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Gastrointestinal disorders Crohn's Disease	2.5% 3/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
General disorders Complication of device removal	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Infections and infestations Clostridium difficile infection	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Immune system disorders Serum sickness	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.

Other adverse events

Other adverse events
Measure	MRE, Patency Capsule (if Needed), CE, and IC n=119 participants at risk Single-arm study, which includes MRE procedure, Patency Capsule Procedure (if needed), PillCam Crohn's Capsule Endoscopy Procedure and Ileocolonoscopy procedure. Capsule Endoscopy: At baseline subject will under the PillCam Crohn's Capsule Procedure
Gastrointestinal disorders Abdominal pain	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Gastrointestinal disorders Constipation	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Gastrointestinal disorders Haematochezia	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Gastrointestinal disorders Haemorrhoids	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
General disorders Infusion site extravasation	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Infections and infestations Oesophageal candidiasis	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Infections and infestations Staphylococcal skin infection	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Injury, poisoning and procedural complications Infusion related reaction	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Injury, poisoning and procedural complications Post procedural complication	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Investigations Haemoglobin decreased	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Musculoskeletal and connective tissue disorders Arthralgia	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Musculoskeletal and connective tissue disorders Myalgia	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
Psychiatric disorders Emotional distress	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.
General disorders Fatigue	0.84% 1/119 • 6 weeks plus 30 days - Events will be collected for all enrolled subjects with the start of baseline imaging procedures (MRE) and end 14 days following completion of the IC procedure. Subjects with Adverse Event (AE) 14 days following the IC procedure will be followed for 30 days or until event resolves, whichever comes first.

Additional Information

Amanda Wenisch, Clinical Resaerch Coordinator / Study Manager

Medtronic GIH

Phone: 1-206-225-4025

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place