Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Conditions
Keywords
Esophageal Fistula, Esophageal Neoplasms, Esophageal Perforation, Esophageal Stenosis, Stents
Brief summary
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
Interventions
DEVICEEvolution® Esophageal Stent - Fully Covered
Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
Sponsors
Cook Group Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak * Physician plans to remove the stent within the duration of study follow-up
Exclusion criteria
* Patient is \< 18 years of age * Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule * Patient is pregnant, lactating, or planning on being pregnant within the next 6 months * Patient is simultaneously participating in another investigational drug or device study * Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement * Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Successful Removal of Study Stent | 7 days to 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Benign Indications That Achieved Clinical Success | 7 days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 130 |
| Total | 130 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Complete stent migration through digestive tract | 1 |
| Overall Study | Death | 7 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Non study stent placed | 2 |
| Overall Study | Six month Follow up completed, stent not removed | 2 |
| Overall Study | Study Device Not Placed | 3 |
Baseline characteristics
| Characteristic | Evolution® Esophageal Stent |
|---|---|
| Age, Continuous | 61.1 years STANDARD_DEVIATION 13.5 |
| Race/Ethnicity, Customized Ethnicity Black | 11 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 16 Participants |
| Race/Ethnicity, Customized Ethnicity White | 103 Participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 130 |
| other Total, other adverse events | 94 / 130 |
| serious Total, serious adverse events | 46 / 130 |
Outcome results
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.
Time frame: 7 days to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evolution® Esophageal Stent | Number of Patients With Successful Removal of Study Stent | 57 Participants |
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.
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Evolution® Esophageal Stent | Number of Patients With Benign Indications That Achieved Clinical Success | 44 Participants |