Trial Outcomes & Findings for Spy II Clinical Registry (NCT NCT00751998)
NCT ID: NCT00751998
Last Updated: 2021-08-19
Results Overview
Recruitment status
COMPLETED
Target enrollment
297 participants
Primary outcome timeframe
During Procedure
Results posted on
2021-08-19
Participant Flow
Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.
Participant milestones
| Measure |
Arm 1
Test of SpyGlass device
|
|---|---|
|
Overall Study
STARTED
|
297
|
|
Overall Study
COMPLETED
|
277
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
Arm 1
Test of SpyGlass device
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Death
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Spy II Clinical Registry
Baseline characteristics by cohort
| Measure |
Arm 1
n=297 Participants
Test of SpyGlass device
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
157 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
140 Participants
n=39 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 16.2 • n=39 Participants
|
|
Sex: Female, Male
Female
|
152 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
145 Participants
n=39 Participants
|
|
Region of Enrollment
France
|
15 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
224 participants
n=39 Participants
|
|
Region of Enrollment
Belgium
|
11 participants
n=39 Participants
|
|
Region of Enrollment
Denmark
|
10 participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
26 participants
n=39 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: During ProcedureOutcome measures
| Measure |
Arm 1
n=297 Participants
Test of SpyGlass device
|
|---|---|
|
Procedural Success as Defined by: 1. Ability to Visualize Stricture & Obtain Biopsy of Lesion Adequate for Histological Examination in Suspected Malignancy Cases or 2. Ability to Visualize Stone(s) & Successfully Initiate Stone Fragmentation & Removal.
|
89 percent
Interval 84.0 to 92.0
|
Adverse Events
Arm 1
Serious events: 81 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=297 participants at risk
Test of SpyGlass device
|
|---|---|
|
Hepatobiliary disorders
Stent Migration
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Bacteremia
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Escherichia Bacteremia
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Sepsis
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Bacterial Sepsis
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Blood and lymphatic system disorders
Heparin induced Thrombocytopenia
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Septicemia
|
1.0%
3/297 • Number of events 3 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Renal and urinary disorders
Ureteral Obstruction
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Partial Small Bowel Obstruction
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Urinary Tract Infection
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Blood and lymphatic system disorders
Anemia
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Nervous system disorders
Bell's Palsy
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Nervous system disorders
Worsening of Left C5-6 Radiculopathy
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Fever
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Cholangitis
|
5.1%
15/297 • Number of events 15 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
End Stage Liver Disease
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinamatosis
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Enterocutaneous Fistula
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Perforation of Bile Duct
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.7%
5/297 • Number of events 7 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Elevated Liver Function Tests
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Hepatitis C
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Liver Transplant Rejection
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Infection
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progression of malignancy
|
3.0%
9/297 • Number of events 9 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Injury, poisoning and procedural complications
Fall
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Vascular disorders
Abdominal Aortic Aneurysm Repair with Stent Graft
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Pancreatitis
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile Duct Resection due to Colon Cancer
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Abdominal Distress
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Cardiac disorders
Unknown Cardiovascular Event
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Obstruction of Bile Duct
|
1.7%
5/297 • Number of events 5 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Respiratory, thoracic and mediastinal disorders
Transient Desaturation
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.67%
2/297 • Number of events 2 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Liver Abcess
|
1.3%
4/297 • Number of events 4 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Probable Ileus
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diagnosis of Cancer of the Pancreas
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Cardiac disorders
Pericarditis and effusion
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Liver Failure
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Musculoskeletal and connective tissue disorders
Umbilical Hernia Repair
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Duct of Luschka Biliary Leak with Extrahepatic Biliary Stricture
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Vascular disorders
Hypotension
|
1.0%
3/297 • Number of events 3 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Biliary Stent Replacement
|
1.0%
3/297 • Number of events 3 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Esophageal Variceal Bleeding
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Abdominal Distention
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Psychiatric disorders
Hallucination
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Choledocal Cyst
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Delayed Return of Bowel Function
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Infections and infestations
Biloma with Possible Superinfection
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Injury, poisoning and procedural complications
Post ERCP Nausea
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Intra-abdominal Hemorrhage Post Planned Surgical Intervention
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Cardiac disorders
Probable Acute Myocardial Infarction
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Immune system disorders
Inflammatory Syndrome
|
1.3%
4/297 • Number of events 6 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Dysfunction of Pancreatic Stent
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Hospitalization for EUS and Abdominal Ultrasound
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Hepatobiliary disorders
Hospitalization to Repeat ERCP & Continue Bile Duct Investigation
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
|
Gastrointestinal disorders
Constipation
|
0.34%
1/297 • Number of events 1 • 2 Years, 5 Months, & 17 Days
Adverse Events were collected from procedure through end of study for all subjects.
|
Other adverse events
Adverse event data not reported
Additional Information
Joyce Peetermans, PhD, Director Endoscopy Clinical
Boston Scientific Corporation
Phone: 508-683-4211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place