Endoscopy, Feeding Tube Complication, Hemostasis, Perforation Colon
Conditions
Brief summary
This study is intended to document procedural and clinical effectiveness in consecutive cases in which at least one MANTIS clip is selected, pertaining to use of a new endoscopic clipping device MANTIS™ including but not limited to hemostasis, closure, anchoring and marking.
Detailed description
To document clinical effectiveness and safety when used per indication within the GI tract for the purpose of: 1. Endoscopic marking 2. Hemostasis for: * Mucosal/sub-mucosal defects \< 3 cm * Bleeding ulcers * Arteries \< 2 mm * Polyps \< 1.5 cm in diameter * Diverticula in the colon * Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel 4. As a supplementary method, closure of GI tract luminal perforations \< 20 mm that can be treated conservatively
Interventions
DEVICEEndoscopic clip placement in the gastrointestinal tract.
The placement of a mechanical endoscopic clip in the gastrointestinal tract.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subject indicated for endoscopic clipping per local standard of practice. * Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion criteria
* Subjects who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor. * Subjects who the investigator deems at risk for study device or procedure related complications per the Instructions for Use (IFU). where commercially available or the Investigator Brochure (IB) for countries where the study device is not approved.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hemostasis of Active Bleeding | Index Procedure | Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure |
| Number of Participants With Prophylactic Hemostasis | Up to 30 Days after the index clipping procedure | Clinical success defined as hemostasis as a prophylactic measure to minimize risk of a delayed bleeding post lesion resection, defined as absence of a bleeding SAE up to 30 days after the index clipping procedure |
| Number of Lesions With Defect Closures | Index Procedure | Clinical success defined as defect closure |
| Number of Participants With Serious Adverse Events | Up to 30 Days after the Endocsopic clipping procedure | Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure |
Countries
Canada, China, Hong Kong, India, Japan, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MANTIS Clipping Study Subject indicated for endoscopic clipping per local standard of practice | 240 |
| Total | 240 |
Baseline characteristics
| Characteristic | MANTIS Clipping Study |
|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 13.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 217 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 57 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 159 Participants |
| Region of Enrollment Canada | 61 participants |
| Region of Enrollment China | 11 participants |
| Region of Enrollment Hong Kong | 23 participants |
| Region of Enrollment India | 14 participants |
| Region of Enrollment Japan | 4 participants |
| Region of Enrollment United States | 127 participants |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 134 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 240 |
| other Total, other adverse events | 0 / 240 |
| serious Total, serious adverse events | 14 / 240 |
Outcome results
Primary
Number of Lesions With Defect Closures
Clinical success defined as defect closure
Time frame: Index Procedure
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| MANTIS Clipping Study | Number of Lesions With Defect Closures | 4 Lesions |
Primary
Number of Participants With Hemostasis of Active Bleeding
Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Time frame: Index Procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTIS Clipping Study | Number of Participants With Hemostasis of Active Bleeding | 239 Participants |
Primary
Number of Participants With Prophylactic Hemostasis
Clinical success defined as hemostasis as a prophylactic measure to minimize risk of a delayed bleeding post lesion resection, defined as absence of a bleeding SAE up to 30 days after the index clipping procedure
Time frame: Up to 30 Days after the index clipping procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTIS Clipping Study | Number of Participants With Prophylactic Hemostasis | 164 Participants |
Primary
Number of Participants With Serious Adverse Events
Rate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure
Time frame: Up to 30 Days after the Endocsopic clipping procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MANTIS Clipping Study | Number of Participants With Serious Adverse Events | 10 Participants |