Trial Outcomes & Findings for Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy (NCT NCT01085513)

NCT ID: NCT01085513

Last Updated: 2020-07-22

Results Overview

Patients were indicated for small bowel manometry based on one or both of the following symptoms: * Pseudo obstruction * Unintentional body weight loss

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 143 participants
• Primary outcome timeframe: Up to 7 months
• Results posted on: 2020-07-22

Participant Flow

Participant milestones

Measure	Patients Patients previously indicated for manometry	Healthy Volunteers Healthy volunteers
Phase I - Development Phase STARTED	54	52
Phase I - Development Phase COMPLETED	54	52
Phase I - Development Phase NOT COMPLETED	0	0
Phase II - Validation Phase STARTED	21	16
Phase II - Validation Phase COMPLETED	21	16
Phase II - Validation Phase NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy

Baseline characteristics by cohort

Measure	Patients n=75 Participants Patients previously indicated for manometry PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.	Healthy Volunteers n=68 Participants Healthy volunteers PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.	Total n=143 Participants Total of all reporting groups
Age, Continuous	40.2 years STANDARD_DEVIATION 15.34 • n=5 Participants	40.5 years STANDARD_DEVIATION 13.6 • n=7 Participants	40.34 years STANDARD_DEVIATION 14.49 • n=5 Participants
Age, Categorical <=18 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=5 Participants	64 Participants n=7 Participants	132 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	43 Participants n=7 Participants	96 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	25 Participants n=7 Participants	47 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	0 participants n=7 Participants	7 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants
Region of Enrollment Spain	37 participants n=5 Participants	47 participants n=7 Participants	84 participants n=5 Participants
Region of Enrollment Italy	16 participants n=5 Participants	3 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Sweden	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 7 months

Population: Total of 143 cases were enrolled. Phase 1- total of 106 cases (52 healthy volunteers, 54 patients) provided sensitivity and specificity results to train an algorithm. Phase 2- total of 37 cases (16 healthy volunteers, 21 patients) was intended to validate the sensitivity/specificity but study was terminated and the 37 cases were not analyzed.

Patients were indicated for small bowel manometry based on one or both of the following symptoms:

• Pseudo obstruction
• Unintentional body weight loss

Outcome measures

Measure	Healthy Volunteers n=52 Participants Healthy volunteers PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.	Patients n=54 Participants Patients previously indicated for manometry PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility Sensitivity	90 percentage	90 percentage
To Evaluate Accuracy of Endoluminal Image Analysis by Capsule Endoscopy in Detecting Severe Dysmotility Specificity	100 percentage	100 percentage

SECONDARY outcome

Timeframe: Up to 7 months

Population: The 2ndary outcome was to be calculated from subjects in Phase 2 (i.e. the validation phase) of the study but the study was terminated and the 37 participants in phase 2 were not analyzed

The study was terminated without achieving the needed sample size due to very low recruitment rate. Therefore, no statistical analysis has been performed to achieve the secondary outcome.

Outcome measures

Outcome data not reported

Adverse Events

Patients

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Patients n=75 participants at risk Patients previously indicated for manometry Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea. In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days.	Healthy Volunteers n=68 participants at risk Healthy volunteers PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.
Gastrointestinal disorders Abdominal Pain	1.3% 1/75 • Number of events 1 • AE information was collected as occurs from screening visit through follow up phone call which could occur over up to 7 months	0.00% 0/68 • AE information was collected as occurs from screening visit through follow up phone call which could occur over up to 7 months
Gastrointestinal disorders Nausea	1.3% 1/75 • Number of events 1 • AE information was collected as occurs from screening visit through follow up phone call which could occur over up to 7 months	0.00% 0/68 • AE information was collected as occurs from screening visit through follow up phone call which could occur over up to 7 months

Additional Information

director of clinical affairs

Given Imaging

Phone: +972-4-9097774

Email: Hila.debby@givenimaging.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place