Trial Outcomes & Findings for MANTIS Endoscopic Clipping Study (NCT NCT05653843)
NCT ID: NCT05653843
Last Updated: 2025-08-12
Results Overview
Clinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Recruitment status
COMPLETED
Target enrollment
240 participants
Primary outcome timeframe
Index Procedure
Results posted on
2025-08-12
Participant Flow
Participant milestones
| Measure |
MANTIS Clipping Study
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Overall Study
STARTED
|
240
|
|
Overall Study
COMPLETED
|
240
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
Baseline characteristics by cohort
| Measure |
MANTIS Clipping Study
n=240 Participants
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 13.7 • n=240 Participants
|
|
Sex: Female, Male
Female
|
106 Participants
n=240 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
217 Participants
n=240 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=240 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
Asian
|
57 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
White
|
159 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=229 Participants • Hispanic or Latino data were collected for both ethnicity and race. For purposes of this Measure Hispanic or Latino were excluded from the overall count.
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
11 Participants
n=240 Participants
|
|
Region of Enrollment
Canada
|
61 participants
n=240 Participants
|
|
Region of Enrollment
Hong Kong
|
23 participants
n=240 Participants
|
|
Region of Enrollment
United States
|
127 participants
n=240 Participants
|
|
Region of Enrollment
Japan
|
4 participants
n=240 Participants
|
|
Region of Enrollment
China
|
11 participants
n=240 Participants
|
|
Region of Enrollment
India
|
14 participants
n=240 Participants
|
PRIMARY outcome
Timeframe: Index ProcedureClinical success defined as hemostasis of an active bleeding assessed at the time of the index clipping procedure
Outcome measures
| Measure |
MANTIS Clipping Study
n=240 Participants
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Number of Participants With Hemostasis of Active Bleeding
|
239 Participants
|
PRIMARY outcome
Timeframe: Up to 30 Days after the index clipping procedureClinical 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
Outcome measures
| Measure |
MANTIS Clipping Study
n=172 Participants
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Number of Participants With Prophylactic Hemostasis
|
164 Participants
|
PRIMARY outcome
Timeframe: Index ProcedureClinical success defined as defect closure
Outcome measures
| Measure |
MANTIS Clipping Study
n=249 Lesions
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Number of Lesions With Defect Closures
|
4 Lesions
|
PRIMARY outcome
Timeframe: Up to 30 Days after the Endocsopic clipping procedureRate of serious adverse events (SAEs) related to the MANTIS clip or the endoscopic study portion of the procedure
Outcome measures
| Measure |
MANTIS Clipping Study
n=240 Participants
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Number of Participants With Serious Adverse Events
|
10 Participants
|
Adverse Events
MANTIS Clipping Study
Serious events: 14 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MANTIS Clipping Study
n=240 participants at risk
Subject indicated for endoscopic clipping per local standard of practice
|
|---|---|
|
Gastrointestinal disorders
Caecal perforation
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Death - Worsening sepsis
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Aspiration
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Diverticular bleed - site unknown
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
GI Mucosal injury
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Intrasubmucosal leak
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Ischemia colitis
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Left lower abdominal pain
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Nausea
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Ongoing lower GI bleeding
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Post EMR lower GI Bleeding
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Post-Polypectomy Syndrome
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
|
Gastrointestinal disorders
Septic shock
|
0.42%
1/240 • Number of events 1 • Up to 36 days post index procedure
|
Other adverse events
Adverse event data not reported
Additional Information
Andrea Burbage, Principal Clinical Trial Manager
Boston Scientific
Phone: 7812544679
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place