Prospective Multicenter Feasibility Study of HANAROSTENT Naturfit Colonic Stent

Prospective Multicenter Feasibility Study of HANAROSTENT Naturfit Colonic Stent - HANAROSTENT Naturfit Colonic Stent prospective feasibility study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000035224

Enrollment

200

Registered

2018-12-12

Start date

2019-02-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

malignant colo-rectal strictures

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients requiring palliative treatment of colorectal strictures produced by malignant neoplasms. Only patients with no previous colonic stenting will be included in the registry.

Exclusion criteria

Exclusion criteria: Patients contraindicated will include those presenting - enteral ischemia - benign stricture - suspected or impending perforation - intrabdominal abscess / perforation - strictures that do not allow passage of a guide wire - patients for whom endoscopic techniques are contraindicated - any use other than those specifically outlined under indications of use (inclusion)

Design outcomes

Primary

Measure	Time frame
Clinical Efficacy of HANAROSTENT Naturfit Colonic Stent, associated to Obstruction Relief and Permeability	—

Secondary

Measure	Time frame
Additional data related to the procedure and the product: Technical success, Complications, Survival, Palliation vs Bridge to Surgery	—

Countries

Japan

Contacts

Public ContactRyo Otsuka

Yokohama Shin-Midori General Hospital Division of Surgery, Gastrointestinal Center

rotsuka7791@gmail.com045-984-2400

Outcome results