Trial Outcomes & Findings for Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope (NCT NCT05429203)

NCT ID: NCT05429203

Last Updated: 2025-09-15

Results Overview

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 319 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2025-09-15

Participant Flow

Participant milestones

Measure	Duodenoscope With Disposable Distal End Caps Patients will undergo endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope Patients will undergo ERCP using a conventional duodenoscope.
Overall Study STARTED	159	160
Overall Study COMPLETED	159	160
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Duodenoscope With Single-use Distal Cover and the Conventional Reusable Duodenoscope

Baseline characteristics by cohort

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.	Total n=319 Participants Total of all reporting groups
Age, Continuous	64.5 years n=5 Participants	65 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	74 Participants n=7 Participants	130 Participants n=5 Participants
Sex: Female, Male Male	103 Participants n=5 Participants	86 Participants n=7 Participants	189 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	41 Participants n=5 Participants	48 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	27 Participants n=5 Participants	33 Participants n=7 Participants	60 Participants n=5 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	62 Participants n=7 Participants	137 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Region of Enrollment United States	159 Participants n=5 Participants	160 Participants n=7 Participants	319 Participants n=5 Participants
Previous ERCP Index	45 Participants n=5 Participants	44 Participants n=7 Participants	89 Participants n=5 Participants
Previous ERCP Repeat	114 Participants n=5 Participants	116 Participants n=7 Participants	230 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes were assessed for superficial mucosal injury, perforation of the stomach or intestine, mucosal bleeding, pancreatitis, infection, death or any other symptom reported by the patient.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Number of Participants With Procedure-related Adverse Events	8 Participants	9 Participants

SECONDARY outcome

Timeframe: Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Maneuverability: Intubation Into Esophagus Rating = 1	153 Participants	154 Participants
Duodenoscope Maneuverability: Intubation Into Esophagus Rating = 2	5 Participants	5 Participants
Duodenoscope Maneuverability: Intubation Into Esophagus Rating = 3	1 Participants	1 Participants
Duodenoscope Maneuverability: Intubation Into Esophagus Rating = 4	0 Participants	0 Participants
Duodenoscope Maneuverability: Intubation Into Esophagus Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Maneuverability: Passage Into Stomach Rating = 1	153 Participants	155 Participants
Duodenoscope Maneuverability: Passage Into Stomach Rating = 2	3 Participants	2 Participants
Duodenoscope Maneuverability: Passage Into Stomach Rating = 3	3 Participants	2 Participants
Duodenoscope Maneuverability: Passage Into Stomach Rating = 4	0 Participants	1 Participants
Duodenoscope Maneuverability: Passage Into Stomach Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Maneuverability: Navigation Across Pylorus Rating = 1	151 Participants	155 Participants
Duodenoscope Maneuverability: Navigation Across Pylorus Rating = 2	3 Participants	4 Participants
Duodenoscope Maneuverability: Navigation Across Pylorus Rating = 3	1 Participants	1 Participants
Duodenoscope Maneuverability: Navigation Across Pylorus Rating = 4	2 Participants	0 Participants
Duodenoscope Maneuverability: Navigation Across Pylorus Rating = 5	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Maneuverability: Achieving Short Position of the Scope Rating = 1	154 Participants	155 Participants
Duodenoscope Maneuverability: Achieving Short Position of the Scope Rating = 2	3 Participants	4 Participants
Duodenoscope Maneuverability: Achieving Short Position of the Scope Rating = 3	2 Participants	1 Participants
Duodenoscope Maneuverability: Achieving Short Position of the Scope Rating = 4	0 Participants	0 Participants
Duodenoscope Maneuverability: Achieving Short Position of the Scope Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Maneuverability will be assessed only during the procedure (approximately 10 minutes)

Providers assessed the 2 duodenoscopes for maneuverability during the procedure in patients undergoing ERCP, using a previously defined scoring system which uses a 5-point scale ranging from 1 to 5, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Maneuverability: Achieving Optimal Papillary Position Rating = 1	154 Participants	154 Participants
Duodenoscope Maneuverability: Achieving Optimal Papillary Position Rating = 2	4 Participants	4 Participants
Duodenoscope Maneuverability: Achieving Optimal Papillary Position Rating = 3	1 Participants	2 Participants
Duodenoscope Maneuverability: Achieving Optimal Papillary Position Rating = 4	0 Participants	0 Participants
Duodenoscope Maneuverability: Achieving Optimal Papillary Position Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Rating = 1	155 Participants	155 Participants
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Rating = 2	4 Participants	5 Participants
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Rating = 3	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Rating = 4	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Scope Stiffness Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no water leakage or no difficulty in applying suction or inflating air, 2 minimal leakage or minimal difficulty with suction or inflation, 3 moderate leakage or difficulty, 4 severe leakage or difficulty and 5 unable to perform the requisite function.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Rating = 2	3 Participants	4 Participants
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Rating = 3	1 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Rating = 4	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Rating = 5	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality Rating = 1	155 Participants	156 Participants

SECONDARY outcome

Timeframe: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being easy to perform, 2 minimal difficulty, 3 moderate difficulty, 4 severe difficulty and 5 unable to complete the requisite maneuver.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Rating = 1	157 Participants	158 Participants
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Rating = 2	1 Participants	2 Participants
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Rating = 3	1 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Rating = 4	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Mechanical characteristics assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their mechanical characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being no strain, 2 minimal strain, 3 moderate strain, 4 severe strain and 5 unable to complete the procedure.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Mechanical Characteristics Profile: Hand Strain Rating = 1	157 Participants	158 Participants
Duodenoscope Mechanical Characteristics Profile: Hand Strain Rating = 2	2 Participants	2 Participants
Duodenoscope Mechanical Characteristics Profile: Hand Strain Rating = 3	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Hand Strain Rating = 4	0 Participants	0 Participants
Duodenoscope Mechanical Characteristics Profile: Hand Strain Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Imaging Characteristics Profile: Image Quality Rating = 1	154 Participants	154 Participants
Duodenoscope Imaging Characteristics Profile: Image Quality Rating = 2	4 Participants	4 Participants
Duodenoscope Imaging Characteristics Profile: Image Quality Rating = 3	1 Participants	2 Participants
Duodenoscope Imaging Characteristics Profile: Image Quality Rating = 4	0 Participants	0 Participants
Duodenoscope Imaging Characteristics Profile: Image Quality Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Imaging characteristics were assessed only during the procedure (approximately 15 minutes)

Providers assessed the 2 duodenoscopes for their imaging characteristics during the procedure in patients undergoing ERCP. Each characteristic was assessed using a published 5-point scoring system, with 1 being superior, 2 good, 3 satisfactory, 4 suboptimal and 5 unable to visualize or achieve stability of image resulting in termination of procedure.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Duodenoscope Imaging Characteristics Profile: Image Stability Rating = 1	156 Participants	157 Participants
Duodenoscope Imaging Characteristics Profile: Image Stability Rating = 2	3 Participants	3 Participants
Duodenoscope Imaging Characteristics Profile: Image Stability Rating = 3	0 Participants	0 Participants
Duodenoscope Imaging Characteristics Profile: Image Stability Rating = 4	0 Participants	0 Participants
Duodenoscope Imaging Characteristics Profile: Image Stability Rating = 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30-60 minutes

Patients undergoing Endoscopic retrograde cholangiopancreatography (ERCP) using either of the 2 duodenoscopes will be assessed for their ability to perform endoscopic maneuvers like sphincterotomy, balloon sweep, use of basket/mechanical lithotriptor, stone clearance, stricture dilation using balloon/catheter, stent insertion, stent removal and use of single operator cholangioscopy/pancreatoscopy.

Outcome measures

Measure	Duodenoscope With Disposable Distal End Caps n=159 Participants Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 Participants Patients will undergo ERCP using a conventional duodenoscope.
Number of Participant With Procure Success (Ability to Perform Interventions)	154 Participants	155 Participants

Adverse Events

Duodenoscope With Disposable Distal End Caps

Serious events: 8 serious events

Other events: 8 other events

Deaths: 1 deaths

Conventional Reusable Duodenoscope

Serious events: 9 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Duodenoscope With Disposable Distal End Caps n=159 participants at risk Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 participants at risk Patients will undergo ERCP using a conventional duodenoscope.
Gastrointestinal disorders Post ERCP pancreatitis (PEP)	3.8% 6/159 • 3 months	3.1% 5/160 • 3 months
Surgical and medical procedures Post-sphincterotomy bleeding	0.63% 1/159 • 3 months	1.9% 3/160 • 3 months
Hepatobiliary disorders Cholangitis	0.63% 1/159 • 3 months	0.62% 1/160 • 3 months
Surgical and medical procedures Perforation	0.63% 1/159 • 3 months	0.62% 1/160 • 3 months
Hepatobiliary disorders Liver failure	0.63% 1/159 • 3 months	0.00% 0/160 • 3 months

Other adverse events

Measure	Duodenoscope With Disposable Distal End Caps n=159 participants at risk Patients will undergo ERCP using a duodenoscope with a single-use distal cover.	Conventional Reusable Duodenoscope n=160 participants at risk Patients will undergo ERCP using a conventional duodenoscope.
Gastrointestinal disorders Abdomen pain (without post-ERCP pancreatitis)	5.0% 8/159 • 3 months	5.0% 8/160 • 3 months

Additional Information

Subhas Banerjee, MD

Stanford University

Phone: (650) 736-5555

Email: subhas.banerjee@stanford.edu

Results disclosure agreements

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