CClinicalTrials.gg
Status unknownNCT05443815HemoCERUpdated Jul 8, 2022

Registry on the Use of HaemoCER-Plus in the Treatment and Prevention of Post-resectional Bleeding

An observational study in Post-resectional Bleeding, sponsored by Istituto Clinico Humanitas Mater Domini. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-08.

Sponsored by Istituto Clinico Humanitas Mater Domini · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

Gastrointestinal bleeding is defined as clinical evidence of bleeding manifested by melena, hematochezia that required endoscopic hemostasis. GI bleeding associated to endoscopic procedure is defined as clinical evidence of bleeding and a drop in hemoglobin of ≥ 2g/dL on the day of the procedure (early bleeding) or up to 14 days after the procedure (delayed bleeding).GI bleeding is, nevertheless, a common complication of endoscopic procedures, such as endoscopic mucosal resection (EMR) and endoscopic sub mucosal dissection (ESD). For example, colorectal ESD, which is technically more difficult than gastric or esophageal ESD because of the anatomical features of the colon, present an increased risk of delayed bleeding. According to literature, early bleeding occurs on average in 5,3% of endoscopic resections of the whole digestive tract, with bleeding rates per location as follows: esophagus 9.4%, stomach 9.1%, duodenum 3.6%, colon 3.4%. Concerning delayed bleeding, it is assessed to complicate 3.1% of endoscopic resection procedures. The bleeding rate in the duodenum is usually the highest (6.3%), followed by colon at (3.6%), stomach (1.5%) and esophagus (0.9%). Age, lesion size and piecemeal resection are associated with an increased risk of bleeding. Usage of aspirin or NSAIDs seems to not increase risk of post-polypectomy bleeding, while clopidogrel and warfarin do and should be discontinued in the periprocedural period to prevent the occurrence of post-polypectomy bleeding. Direct oral anticoagulants (DOAC) administration shows similar post-procedural gastrointestinal bleeding risk to anti-vitamin K antagonists (VKA) administration in patients undergoing endoscopic procedures.

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Conditions studied

  • Post-resectional Bleeding

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's planned enrollment of 50 is below the median of 150 across 893 observational studies indexed under Hemorrhage.

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Lead sponsor

Istituto Clinico Humanitas Mater Domini is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

This will be a multicenter and observational registry of patients treated with HaemoCer- PLUS to obtain hemostasis.

All centres participating in the project will select the patients according to the in- and exclusion criteria. Ethical approval will be obtained in every participant hospital. All patients entering this new registry will have to sign a patient inform consent.

Inclusion criteria

  • patients who had authorized to use and process their personal details for the purpose of research;
  • patients able to express their consent;
  • age >18 years;
  • endoscopic procedures where HaemoCer-PLUS has been used for hemostasis or prevention of bleeding

Exclusion criteria

Exclusion Criteria:

  • hemostatic therapies other than HaemoCer-PLUS
  • Known coagulopathy likely to affect risk of bleeding.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • HaemoCer-PLUS

    Patients who had receive HaemoCer-PLUS

    Device: HaemoCer-PLUS

Interventions

  • DeviceHaemoCer-PLUS

    HaemoCer-PLUS

06

What researchers measure

Primary outcomes

  1. Number and proportion of bleeding events in patients receiving HaemoCer-PLUS

    Number and proportion of bleeding events controlled by application of HaemoCer

    Time frame: 6 months

07

Study locations

1 site
  • Humanitas-Mater Domini
    Castellanza, 21053, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05443815
Lead sponsor
Istituto Clinico Humanitas Mater Domini
Responsible party
Sponsor
First posted
Jul 5, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Jul 30, 2023 (estimated)
Last update
Jul 8, 2022

Study contacts

Benedetto Mangiavillano, MD
Contact
benedetto.mangiavillano@materdomini.it
00390331476381

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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