Spy II Clinical Registry

• Sponsor: Boston Scientific Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00751998
• Collaborator: (none)
• Enrollment: 297
• Locations: 15
• Duration (Months): 35
• Patients Per Site: 19.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

A prospective, multi-center registry for subjects undergoing Endoscopic retrograde Cholangiopancreatography (ERCP) and cholangioscopy for known or suspected pancreaticobiliary disease.

Condition or Disease	Intervention/Treatment	Phase
Biliary Tract Diseases	Device: SpyGlass

Study Design

• Study Type: Observational
• Actual Enrollment: 297 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Clinical Registry to Assess Performance and Clinical Utility of the SpyGlass Direct Visualization System
• Study Start Date: Nov 1, 2006
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Arm 1 Test of SpyGlass device	Device: SpyGlass; The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.

Outcome Measures

Primary Outcome Measures

1. 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. [During Procedure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female >= 18 years of age

• Willing and able to comply with the Registry procedures and provide written informed consent to participate in the Registry

• Indicated for ERCP or ERCP/cholangioscopy (with or without biopsy)

Exclusion Criteria:

• Subjects for whom endoscopic procedure are medically contraindicated

• Subjects for whom ERCP are medically contraindicated

• Subjects for whom medical condition warrants use of device outside of indication for use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Pacific Medical Center	San Francisco	California	United States	94120
2	University of Colorado Hospital	Aurora	Colorado	United States	80045
3	Indiana University Medical Center	Indianapolis	Indiana	United States	46202-5253
4	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
5	Mayo Clinic	Rochester	Minnesota	United States	55905-0001
6	Columbia University Medical Center	New York	New York	United States	10032
7	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
8	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
9	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15123
10	Medical University of South Carolina	Charleston	South Carolina	United States	29425-0001
11	Erasme Hospital - Belgium	Brussels		Belgium	1070
12	Bispebjerg Hospital, Denmark	Kobenhavn NV		Denmark	2400
13	Hopital Edouard Herriot	Lyon, Cedex 03		France	69437
14	Evangelisches Krankenhaus Dusseldorf	Dusseldorf		Germany	D-40217
15	Policlinico Agostino Gemelli	Roma		Italy	00161

Sponsors and Collaborators

• Boston Scientific Corporation

Investigators

• Study Director: Joyce Peetermans, PhD, Boston Scientific Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Boston Scientific Corporation
• ClinicalTrials.gov Identifier: NCT00751998
• Other Study ID Numbers: E7012
• First Posted: Sep 12, 2008
• Last Update Posted: Aug 19, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by Boston Scientific Corporation: biliary; ERCP; cholangioscopy; pancreatic
• Additional relevant MeSH terms: Biliary Tract Diseases

Study Results

Participant Flow

Recruitment Details	Between November 27, 2006 and April 4, 2008 a total of 297 subjects were enrolled.

Arm/Group Title	Arm 1
Arm/Group Description	Test of SpyGlass device
Period Title: Overall Study
STARTED	297
COMPLETED	277
NOT COMPLETED	20

Baseline Characteristics

Arm/Group Title	Arm 1
Arm/Group Description	Test of SpyGlass device
Overall Participants	297
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	157 52.9%
>=65 years	140 47.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.9 (16.2)
Sex: Female, Male (Count of Participants)
Female	152 51.2%
Male	145 48.8%
Region of Enrollment (participants) [Number]
France	15 5.1%
United States	224 75.4%
Belgium	11 3.7%
Denmark	10 3.4%
Germany	26 8.8%
Italy	11 3.7%

Outcome Measures

1. Primary Outcome

Title	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.
Time Frame	During Procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1
Arm/Group Description	Test of SpyGlass device
Measure Participants	297
Number (95% Confidence Interval) [percent]	89

Adverse Events

Time Frame	2 Years, 5 Months, & 17 Days
Adverse Event Reporting Description	Adverse Events were collected from procedure through end of study for all subjects.
Arm/Group Title	Arm 1
Arm/Group Description	Test of SpyGlass device
All Cause Mortality
	Arm 1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	81/297 (27.3%)
Blood and lymphatic system disorders
Heparin induced Thrombocytopenia	1/297 (0.3%)	1
Neutropenia	1/297 (0.3%)	1
Anemia	2/297 (0.7%)	2
Cardiac disorders
Atrial Fibrillation	1/297 (0.3%)	1
Unknown Cardiovascular Event	1/297 (0.3%)	1
Pericarditis and effusion	1/297 (0.3%)	1
Probable Acute Myocardial Infarction	1/297 (0.3%)	1
Gastrointestinal disorders
Partial Small Bowel Obstruction	1/297 (0.3%)	1
Enterocutaneous Fistula	1/297 (0.3%)	1
Abdominal Pain	5/297 (1.7%)	7
Abdominal Distress	1/297 (0.3%)	1
Intestinal Perforation	2/297 (0.7%)	2
Probable Ileus	1/297 (0.3%)	1
Esophageal Variceal Bleeding	1/297 (0.3%)	1
Abdominal Distention	1/297 (0.3%)	1
Delayed Return of Bowel Function	1/297 (0.3%)	1
Intra-abdominal Hemorrhage Post Planned Surgical Intervention	1/297 (0.3%)	1
Hospitalization for EUS and Abdominal Ultrasound	1/297 (0.3%)	1
Constipation	1/297 (0.3%)	1
Hepatobiliary disorders
Stent Migration	2/297 (0.7%)	2
Cholangitis	15/297 (5.1%)	15
End Stage Liver Disease	2/297 (0.7%)	2
Perforation of Bile Duct	1/297 (0.3%)	1
Elevated Liver Function Tests	2/297 (0.7%)	2
Hepatitis C	1/297 (0.3%)	1
Liver Transplant Rejection	1/297 (0.3%)	1
Pancreatitis	1/297 (0.3%)	1
Obstruction of Bile Duct	5/297 (1.7%)	5
Liver Abcess	4/297 (1.3%)	4
Liver Failure	1/297 (0.3%)	1
Duct of Luschka Biliary Leak with Extrahepatic Biliary Stricture	1/297 (0.3%)	1
Biliary Stent Replacement	3/297 (1%)	3
Choledocal Cyst	1/297 (0.3%)	1
Cholecystitis	1/297 (0.3%)	1
Dysfunction of Pancreatic Stent	1/297 (0.3%)	1
Hospitalization to Repeat ERCP & Continue Bile Duct Investigation	1/297 (0.3%)	1
Immune system disorders
Inflammatory Syndrome	4/297 (1.3%)	6
Infections and infestations
Bacteremia	1/297 (0.3%)	1
Escherichia Bacteremia	1/297 (0.3%)	1
Sepsis	2/297 (0.7%)	2
Bacterial Sepsis	1/297 (0.3%)	1
Septicemia	3/297 (1%)	3
Urinary Tract Infection	2/297 (0.7%)	2
Fever	2/297 (0.7%)	2
Infection	2/297 (0.7%)	2
Biloma with Possible Superinfection	1/297 (0.3%)	1
Injury, poisoning and procedural complications
Fall	1/297 (0.3%)	1
Post ERCP Nausea	1/297 (0.3%)	1
Musculoskeletal and connective tissue disorders
Flank Pain	1/297 (0.3%)	1
Umbilical Hernia Repair	1/297 (0.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinamatosis	1/297 (0.3%)	1
Progression of malignancy	9/297 (3%)	9
Bile Duct Resection due to Colon Cancer	1/297 (0.3%)	1
Diagnosis of Cancer of the Pancreas	1/297 (0.3%)	1
Nervous system disorders
Bell's Palsy	1/297 (0.3%)	1
Worsening of Left C5-6 Radiculopathy	1/297 (0.3%)	1
Psychiatric disorders
Hallucination	1/297 (0.3%)	1
Renal and urinary disorders
Ureteral Obstruction	1/297 (0.3%)	1
Acute Renal Failure	1/297 (0.3%)	1
Respiratory, thoracic and mediastinal disorders
Pleural Effusion	2/297 (0.7%)	2
Pneumonia	2/297 (0.7%)	2
Transient Desaturation	1/297 (0.3%)	1
Vascular disorders
Deep Vein Thrombosis	1/297 (0.3%)	1
Abdominal Aortic Aneurysm Repair with Stent Graft	1/297 (0.3%)	1
Hypotension	3/297 (1%)	3
Other (Not Including Serious) Adverse Events
	Arm 1
	Affected / at Risk (%)	# Events
Total	0/297 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.