NCT05517369

Brief Summary

This study examines whether the use of Hybrid-ESD+ with LiftUp (Injection solution) results in a higher en bloc and/or R0 rate for non pedunculated colorectal adenomas between 2 and 3 cm than described in the literature for conventional EMR.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2023

Geographic Reach
2 countries

9 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.1 years

First QC Date

August 12, 2022

Last Update Submit

August 17, 2023

Conditions

Colorectal Adenoma

Keywords

Hybrid-ESD+Endoscopic Resection

Outcome Measures

Primary Outcomes (1)

  • R0 resection rate of non pedunculated colorectal polyps between 2 and 3cm using hybrid ESD+

    In how many cases a complete R0 resection (basal and lateral margin) is found on pathologic examination

    after 14 days

Secondary Outcomes (9)

  • Complication rate (perforations, bleeding)

    up to 4 weeks

  • Recurrence rate

    6 months

  • Procedural parameters - Intervention duration

    1 day

  • Procedural parameters - Cleanliness of the colon

    1 day

  • Localization of polyp

    1 day

  • +4 more secondary outcomes

Study Arms (1)

Hybrid-ESD+

EXPERIMENTAL

All participants receive resection of non-pedunculated colorectal polyp between 2 and 3 cm using the Hybrid-ESD+ method.

Procedure: Hybrid ESD+

Interventions

Hybrid ESD+PROCEDURE

Injection of the Lift Up solution, followed by circumcision of the lesion using a snare tip or ESD knife. Using an additional working channel (AWC), the lesion is resected using a grasper and snare.

Hybrid-ESD+

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-pedunculated lesion in the colorectum (epithelial lesion, 2-3 cm).
  • Ablation medically indicated and possible (coagulation, etc. - as determined by the center)

You may not qualify if:

  • Age \< 18 years
  • Pedunculated lesion (Paris0-Ip)
  • Size of the lesion \<2cm or \>3cm
  • Pregnant and breastfeeding women
  • Patient not capable of informed consent / consent not possible
  • Bioptic evidence of a carcinoma / high probability of the presence of a carcinoma
  • Non-lifting sign / known recurrence after previous therapy
  • Impassable stenosis in the colon / rectum
  • Patients with compelling need for therapeutic anticoagulation or dual antiplatelet therapy that cannot be discontinued for resection
  • As per contraindications from the AWC \& LiftUp Instructions for Use:
  • The AWC is not to be used if flexible-endoscopic procedures are contraindicated.
  • The LiftUp gel should not be used when flexible endoscopic procedures are contraindicated, especially in combination with submucosal endoscopic resection (EMR) or endoscopic submucosal dissection (ESD) injectables.
  • LiftUp gel should not be used in patients with known sensitivity to any of the ingredients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Mathilden Hospital Herford

Herford, 32052, Germany

Location

Agaplesion Diakonie Kliniken Kassel

Kassel, 34119, Germany

Location

Klinikum Ludwigsburg

Ludwigsburg, 71640, Germany

Location

St. Franziskus Hospital Münster

Münster, 48145, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

Rems-Murr-Klinikum Winnenden

Winnenden, 71364, Germany

Location

Universitätsklinik Würzburg

Würzburg, 97080, Germany

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Stadtspital Waid

Zurich, 8037, Switzerland

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 26, 2022

Study Start

March 1, 2023

Primary Completion

April 1, 2024

Study Completion

October 1, 2024

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)CH(2)