Removal of the Evolution® Esophageal Stent - Fully Covered | NCT01900691

NCT01900691

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Evolution® Esophageal Stent	Experimental		Device: Evolution® Esophageal Stent - Fully Covered

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Evolution® Esophageal Stent - Fully Covered	Device	Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With Successful Removal of Study Stent	The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.	7 days to 6 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With Benign Indications That Achieved Clinical Success	The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.	7 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
John Vargo, M.D., M.P.H.	The Cleveland Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic		Phoenix	Arizona	85054	United States
Harbor-University of California Los Angeles Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 11, 2013

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Evolution® Esophageal Stent

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Units	Counts
Participants	BG000130

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00061.1± 13.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00041
Male	BG00089

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnicity

Title	Measurements
Black	BG00011
Hispanic or Latino	BG00016

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With Successful Removal of Study Stent

The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.

Posted

Count of Participants

Participants

7 days to 6 months

ID	Title	Description
OG000	Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal

Units	Counts
Participants	OG00058

Title

Denominators

Categories

Title	Measurements
	OG00057

Secondary

Number of Patients With Benign Indications That Achieved Clinical Success

The rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.

Posted

Count of Participants

Participants

7 days

ID	Title	Description
OG000	Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign fistulas, perforations or leaks with the intention of removal

Units	Counts
Participants	OG00078

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Evolution® Esophageal Stent	Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal	10	130	46	130	94	130

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Cardic Arrythmia	Cardiac disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Dysphagia	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0006 events6 affected130 at risk
Anaemia	Blood and lymphatic system disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Leukocytosis	Blood and lymphatic system disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Pancytopenia	Blood and lymphatic system disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Retroperitoneal lymph adenopathy	Blood and lymphatic system disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Abdominal pain	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0005 events5 affected130 at risk
Constipation	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Diarrhea	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Erosive esophagitis	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Gastric perforation	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Hematemesis	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0002 events2 affected130 at risk
Intestinal ischemia	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Malignant gastrointestinal obstruction	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Nausea	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Obstructive pancreatitis	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Esophageal perforation	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Vomiting	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0005 events5 affected130 at risk
Asthenia	General disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Chest discomfort	General disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Chest pain	General disorders	MedRA 10.0	Non-systematic Assessment	EG0007 events7 affected130 at risk
Complication associated with device	General disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Malaise	General disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Non-cardiac chest pain	General disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Sensation of foreign body	General disorders	MedRA 10.0	Non-systematic Assessment	EG0004 events4 affected130 at risk
Bile duct stenosis	Hepatobiliary disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Drug hypersensitivity	Immune system disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Abdominal absces	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Bacteremia	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Bronchitis	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Clostridium difficile infection	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Volvulus	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Fungemia	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Lung abscess	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Pneumonia	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0007 events6 affected130 at risk
Sepsis	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Upper respiratory tract infection	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Urinary tract infection	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Urossepsis	Infections and infestations	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Pharyngeal prforation	Injury, poisoning and procedural complications	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Post procedural hypotension	Injury, poisoning and procedural complications	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Radiation pericarditis	Injury, poisoning and procedural complications	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Decreased appetite	Metabolism and nutrition disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events2 affected130 at risk
Dehydration	Metabolism and nutrition disorders	MedRA 10.0	Non-systematic Assessment	EG0002 events1 affected130 at risk
Failure to thrive	Metabolism and nutrition disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Hypophagia	Metabolism and nutrition disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Malnutrition	Metabolism and nutrition disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Esophageal adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Device dislocation	Product Issues	MedRA 10.0	Non-systematic Assessment	EG00010 events10 affected130 at risk
Confusional state	Psychiatric disorders	MedRA 10.0	Non-systematic Assessment	EG0002 events1 affected130 at risk
Acute kidney injury	Renal and urinary disorders	MedRA 10.0	Non-systematic Assessment	EG0002 events2 affected130 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0003 events3 affected130 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Tracheal compression	Respiratory, thoracic and mediastinal disorders	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Central venous catheterization	Surgical and medical procedures	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Gastrointestinal tube insertion	Surgical and medical procedures	MedRA 10.0	Non-systematic Assessment	EG0001 events1 affected130 at risk
Hypotension	Vascular disorders	MedRA 10.0	Non-systematic Assessment	EG0002 events1 affected130 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Dysphagia	Gastrointestinal disorders	MedRA 10.0	Non-systematic Assessment	EG00020 events20 affected130 at risk
Device dislocation	Product Issues	MedRA 10.0	Non-systematic Assessment	EG00084 events84 affected130 at risk
Chest pain	General disorders	MedRA 10.0	Non-systematic Assessment	EG0009 events9 affected130 at risk

Title	Organization	Phone	Extension	Email
Alan Saunders, MDR, RAC; Manager, Biostatistics	Cook Research Incorporated	765-463-7537	321204	alan.saunders@cookmedical.com

ID	Term
D004937	Esophageal Fistula
D004938	Esophageal Neoplasms
D004939	Esophageal Perforation
D004940	Esophageal Stenosis

Ancestor Terms

ID	Term
D016154	Digestive System Fistula
D004066	Digestive System Diseases
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D005402	Fistula
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D006258	Head and Neck Neoplasms
D014947	Wounds and Injuries

Title

Denominators

Categories

Title	Measurements
	OG00044