Trial Outcomes & Findings for Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS (NCT NCT02524418)

Results Overview

The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

88 participants

Primary outcome timeframe

Day 1

Results posted on

2017-03-30

Participant Flow

Participant milestones

Participant milestones
Measure	Cholangiopancreatoscopy A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Overall Study STARTED	88
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Utility of ERCP Guided Cholangiopancreatoscopy With the SpyGlass DS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cholangiopancreatoscopy n=75 Participants A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants
Region of Enrollment United States	75 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Population: Five of the subjects had both Cholangioscopy and Pancreatoscopy. The results of these procedures were recorded and analyzed separately

The performance of the Spyglass DS during the endoscopy will be based on the ability to reach the target site, obtain samples, and to deliver therapeutic intervention.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=75 Participants A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy n=5 Participants These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Number of Participants With Procedure Technical Success	70 participants	3 participants

SECONDARY outcome

Timeframe: approximately 2 hours

Population: In 20 procedures, the Spyglass equipment set up was done after ERCP started and this time was recorded. The Investigators did not record the set up time for the other procedures.

The time it takes to set up the Spyglass DS and related equipment for the procedure.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=20 Participants A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Time to Set-up the Spyglass DS for the Procedure	5 minutes Interval 2.61 to 7.39	—

SECONDARY outcome

Timeframe: approximately 2 hours

Population: 83 Spyglass procedures were conducted on the 75 participants

Time in minutes will be calculated for completing the procedure with the Spyglass DS.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=83 number of Spyglass procedures A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Measurement of Total Procedure Time Using the Spyglass DS	64.3 minutes Interval 39.1 to 89.4	—

SECONDARY outcome

Timeframe: approximately 2 hours

Population: 83 Spyglass procedures were performed on the 75 participants

The time it takes to perform the diagnostic maneuvers with the SpyGlass DS measured in minutes.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=83 number of Spyglass Proceudres A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Measurement in Minutes for Spyglass DS Diagnostic Maneuvers	27.5 minutes Interval 10.8 to 44.2	—

SECONDARY outcome

Timeframe: approximately 2 hours

Population: For the 75 participants in the study, 83 procedures were completed. Of the 83 procedures, sampling was attempted on 37 procedures in 27 participants.

The time it takes to perform the therapeutic maneuvers with the SpyGlass DS in cases sampling was attempted measured in minutes.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=37 Number of Procedures analyzed A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Measurement in Minutes for Spyglass DS Therapeutic Maneuvers	12.1 minutes Interval 5.76 to 18.44	—

SECONDARY outcome

Timeframe: Day 1

Population: There were a total of 78 Cholangioscopic examinations in the 70 subjects in this study; 35 exam found stones. Where as in the Pancreatoscopy arm 5 participants were evaluated with only 3 exams being evaluable..

The abnormalities found during the procedure, such as ductal stones.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=78 total number of exams A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy n=3 total number of exams These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Number of Cholangioscopic Exams That Detected Ductal Stones	35 exams	2 exams

SECONDARY outcome

Timeframe: Day 1

Population: A total of 78 Cholangioscopic examinations were attempted

The abnormalities found during the procedure, such as strictures.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=78 attempted Cholangioscopic exams A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Strictures Found During the Procedure Will be Measured	27 strictures found	—

SECONDARY outcome

Timeframe: Day 1

Population: Of the 70 Cholangioscopy participants in the study only 44 participants had non-stone lithotripsy-related indications. Spyglass sampling was attempted in 36 procedures.

The mean number of attempts per procedure

Outcome measures

Outcome measures
Measure	Cholangioscopy n=36 Number of procedures analyzed A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Spybite Sampling Attempts Per Procedure	3.94 sampling attempts per procedure Interval 2.47 to 5.41	—

SECONDARY outcome

Timeframe: Day 1

Population: Spyglass-guided stone therapy was attempted in 26 patients with biliary stones

The successful removal of the biliary or pancreas stones will be determined by the need for additional procedures.

Outcome measures

Outcome measures
Measure	Cholangioscopy n=26 Participants A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.	Pancreatoscopy These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
Number of Participants With Successful Removal of the Biliary or Pancreas Stones	24 participants	—

Adverse Events

Cholangiopancreatoscopy

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cholangiopancreatoscopy n=75 participants at risk A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Gastrointestinal disorders periampullary perforation	1.3% 1/75 • Number of events 1

Other adverse events

Other adverse events
Measure	Cholangiopancreatoscopy n=75 participants at risk A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed. Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
Gastrointestinal disorders mild Post ERCP pancreatitis	4.0% 3/75 • Number of events 3

Additional Information

Dr. Peter V. Draganov MD

University of Florida

Phone: 352-273-9472

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place