Trial Outcomes & Findings for Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm (NCT NCT04551014)

Last Updated: 2022-09-01

Results Overview

The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

2 weeks

Results posted on

2022-09-01

Participant Flow

Each polyp sized 4-9 mm underwent block randomization to being removed by cold snare polypectomy (CNP) with or without submucosal injection of EverLift™.

Unit of analysis: Polyps

Participant milestones

Participant milestones
Measure	Polypectomy With EverLift Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Overall Study STARTED	105 142	109 149
Overall Study COMPLETED	105 142	109 149
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of EverLift in the Performance of Polypectomy for Polyps 4-9mm

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Polypectomy With EverLift n=142 Polyps Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=149 Polyps Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.	Total n=291 Polyps Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=93 Participants	27 Participants n=4 Participants	51 Participants n=27 Participants
Age, Categorical >=65 years	81 Participants n=93 Participants	82 Participants n=4 Participants	163 Participants n=27 Participants
Sex/Gender, Customized Female	3 participants n=93 Participants	2 participants n=4 Participants	3 participants n=27 Participants
Sex/Gender, Customized Male	102 participants n=93 Participants	107 participants n=4 Participants	155 participants n=27 Participants
Race/Ethnicity, Customized Asian	3 participants n=93 Participants	3 participants n=4 Participants	4 participants n=27 Participants
Race/Ethnicity, Customized African American	10 participants n=93 Participants	12 participants n=4 Participants	16 participants n=27 Participants
Race/Ethnicity, Customized Hispanic	13 participants n=93 Participants	16 participants n=4 Participants	21 participants n=27 Participants
Race/Ethnicity, Customized White	75 participants n=93 Participants	74 participants n=4 Participants	109 participants n=27 Participants
Race/Ethnicity, Customized Other	4 participants n=93 Participants	4 participants n=4 Participants	8 participants n=27 Participants
Region of Enrollment United States	105 participants n=93 Participants	109 participants n=4 Participants	158 participants n=27 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: Participants with polyps randomized the respective procedure are included in the analysis

The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups.

Outcome measures

Outcome measures
Measure	Polypectomy With EverLift n=142 Polyps Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=149 Polyps Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Number of Polyps With Complete Resection	140 Polyps	145 Polyps

SECONDARY outcome

Timeframe: During the procedure

Population: Participants with polyps randomized the respective procedure are included in the analysis

The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups.

Outcome measures

Outcome measures
Measure	Polypectomy With EverLift n=139 Polyps Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=146 Polyps Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Time to Resection	109.8 Seconds Standard Deviation 56.0	38.8 Seconds Standard Deviation 54.5

SECONDARY outcome

Timeframe: During the procedure (up to 10 minutes)

Population: Participants with polyps randomized the respective procedure are included in the analysis

Outcome measures

Outcome measures
Measure	Polypectomy With EverLift n=142 Polyps Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=149 Polyps Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy.	6 Polyps	5 Polyps

SECONDARY outcome

Timeframe: 4 weeks (from procedure through 30 day follow-up)

Population: Participants with polyps randomized the respective procedure are included in the analysis

Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality.

Outcome measures

Outcome measures
Measure	Polypectomy With EverLift n=105 Participants Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=109 Participants Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Number of Patients With Procedural Complications	1 Participants	2 Participants

Adverse Events

Polypectomy With EverLift

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Polypectomy Without EverLift

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Polypectomy With EverLift n=105 participants at risk Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift.	Polypectomy Without EverLift n=109 participants at risk Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift.
Vascular disorders Splenic artery thrombosis	0.95% 1/105 • 30 days Patients who had the respective procedure were considered at risk for that procedure.	0.92% 1/109 • 30 days Patients who had the respective procedure were considered at risk for that procedure.
Injury, poisoning and procedural complications Post-polypectomy bleeding	0.00% 0/105 • 30 days Patients who had the respective procedure were considered at risk for that procedure.	0.92% 1/109 • 30 days Patients who had the respective procedure were considered at risk for that procedure.

Other adverse events

Adverse event data not reported

Additional Information

Shai Friedland, MD

Stanford University

Phone: 650-723-4000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place