NCT04551014

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

Completed NA Results posted Last updated 1 September 2022

What this trial tests

NA trial testing Use of EverLift in Colo-rectal Cancer in 158 participants. Completed in 15 July 2021.

Timeline

16 September 2020

Primary endpoint
31 May 2021

15 July 2021

Quick facts

Lead sponsor	Stanford University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	158
Start date	16 September 2020
Primary completion	31 May 2021
Estimated completion	15 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Use of EverLift
• Without use of EverLift

Conditions studied

• Colo-rectal Cancer — all drugs for Colo-rectal Cancer →
• Polyp of Colon — all drugs for Polyp of Colon →
• Adenomatous Polyp of Colon — all drugs for Adenomatous Polyp of Colon →

Sponsor

Stanford University

Who can join

18 and older, any sex, with Colo-rectal Cancer or Polyp of Colon. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Polyps With Complete Resection Primary · 2 weeks

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

Group	Value	95% CI
Polypectomy With EverLift	140
Polypectomy Without EverLift	145

Time to Resection Secondary · During the procedure

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

Group	Value	95% CI
Polypectomy With EverLift	109.8	± 56.0
Polypectomy Without EverLift	38.8	± 54.5

Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. Secondary · During the procedure (up to 10 minutes)

Group	Value	95% CI
Polypectomy With EverLift	6
Polypectomy Without EverLift	5

Number of Patients With Procedural Complications Secondary · 4 weeks (from procedure through 30 day follow-up)

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.

Group	Value	95% CI
Polypectomy With EverLift	1
Polypectomy Without EverLift	2

Adverse events — posted to ClinicalTrials.gov

Time frame: 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Polypectomy With EverLift

Serious: 1/105 (1%)

Deaths: 0/105

Polypectomy Without EverLift

Serious: 2/109 (2%)

Deaths: 0/109

Serious adverse events (2 terms)

Reaction	System	Polypectomy With EverLift	Polypectomy Without EverLift
Splenic artery thrombosis	Vascular disorders	—	—
Post-polypectomy bleeding	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Splenic artery thrombosis, Post-polypectomy bleeding.

Data from ClinicalTrials.gov NCT04551014 adverse events section.

Sponsor's own description

The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.