| Primary | Number of Participants With Procedure-related Adverse Events | 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. | | Posted | | Count of Participants | | Participants | | 3 months | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.8 | The a priori threshold for statistical significance was <0.05. | | | | | | | | | | | | | Other | | |
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| Secondary | Duodenoscope Maneuverability: Intubation Into Esophagus | 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. | | Posted | | Count of Participants | | Participants | | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Maneuverability: Passage Into Stomach | 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. | | Posted | | Count of Participants | | Participants | | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Maneuverability: Navigation Across Pylorus | 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. | | Posted | | Count of Participants | | Participants | | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Maneuverability: Achieving Short Position of the Scope | 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. | | Posted | | Count of Participants | | Participants | | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Maneuverability: Achieving Optimal Papillary Position | 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. | | Posted | | Count of Participants | | Participants | | Maneuverability will be assessed only during the procedure (approximately 10 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Mechanical Characteristics Profile: Scope Stiffness | 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. | | Posted | | Count of Participants | | Participants | | Mechanical characteristics assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Mechanical Characteristics Profile: Air-water Button Functionality | 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. | | Posted | | Count of Participants | | Participants | | Mechanical characteristics assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Mechanical Characteristics Profile: Elevator Efficiency | 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. | | Posted | | Count of Participants | | Participants | | Mechanical characteristics assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Mechanical Characteristics Profile: Hand Strain | 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. | | Posted | | Count of Participants | | Participants | | Mechanical characteristics assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Imaging Characteristics Profile: Image Quality | 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. | | Posted | | Count of Participants | | Participants | | Imaging characteristics were assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Duodenoscope Imaging Characteristics Profile: Image Stability | 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. | | Posted | | Count of Participants | | Participants | | Imaging characteristics were assessed only during the procedure (approximately 15 minutes) | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients underwent endoscopic retrograde cholangiopancreatography (ERCP) using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients underwent ERCP using a conventional duodenoscope. |
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| Secondary | Number of Participant With Procure Success (Ability to Perform Interventions) | 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. | | Posted | | Count of Participants | | Participants | | 30-60 minutes | | | | ID | Title | Description |
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| OG000 | Duodenoscope With Disposable Distal End Caps | Patients will undergo ERCP using a duodenoscope with a single-use distal cover. | | OG001 | Conventional Reusable Duodenoscope | Patients will undergo ERCP using a conventional duodenoscope. |
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