Treatment of the head and neck region with HD-AM

Phase 1

Recruiting

• Conditions: ear disease, sinonasal disease, pharyngeal and laryngeal diseases

• Registration Number: JPRN-jRCTs042200040
• Lead Sponsor: Takakura Hiromasa

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1)age, The patients who relatively have good Patient.
2)overall status of(at the agreement acquisition)20 years old or older. (ECOG Performance Status is more than level 2.)
3)
[Ear disease]
(1)Cholesteatoma
Patients who were operated for canal wall down tympanoplasty (without reconstruction of canal wall,or packing mastoid).
(2)Myringoplasty
Patients who have tympanic perforation.
(3)Skin graft on the auricle
Patients who have the auricle disease(carcinoma,etc.).

[sinonasal diseases]
(1)maxillary tumor
Adult patients who will receive a partial maxillectomy for the maxillary tumor.
(2)nasal cavity tumor
Patients who will receive the endoscopic resection for the nasal cavity tumor.
(3)Hypertrophic or Allergic rhinitis
Patients who will receive the endoscopic turbinectomy or mucosal cauterization of the inferior turbinate for hypertrophic or allergic rhinitis.
(4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus.
Patients who will receive the endoscopic modified Lothrop - Draf3 procedure for refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus.

[Oral and laryngopharyngeal diseases]
Patients who are scheduled to have mucous membrane or skin defect due to head and neck surgery.

4)The patients whom it is judged to be available for observation,the testing that conformed to a study enforcement plan and a survey.

Exclusion Criteria

1)
Ear disease
(1)Cholesteatoma
Patients who were operated for canal wall up tympanoplasty (with reconstruction of canal wall, or packing mastoid)
(2)Myringoplasty & (3)Skin graft on the auricle
Bellow 2) to 8)

sinonasal diseases
(1)maxillary tumor
Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
(2)nasal cavity tumor
Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
(3)Hypertrophic or Allergic rhinitis
Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past
(4)Refractory frontal sinusitis, frontal mucocele or tumor in the frontal sinus
Patients who had already received the endoscopic sinus surgery, turbinectomy, mucosal cauterization of the inferior turbinate or a partial maxillectomy in the past

Oral and laryngopharyngeal diseases
Patients who are considered not to be required to compensate for mucocutaneous defects due to the surgical procedure.

2)The patients whom a doctor judged safely for study period if it was difficult hospital visiting and to come home.
3)The patients who complicate eye infection with activity.
4)The patients who plan the enforcement of eye operations for evaluation eyes effective during study period in (we assume the agreement acquisition study initiation).
5)For the group medicine of the planned drug (Xylocaine anesthetic agent, Achromycin) to use during study period, it is the patient with a history of the drug allergy.
6)The patients (saying that, however, the subjects who do not receive the study drug are possible) who participated in other studies or clinical studies within six months.
7)Pregnancy or the childbearing patients who may be pregnant or hope for pregnancy during study period or do not use appropriate contraception.
8)The patients who were judged to be inadequate as an object of this study in testing at agreement acquisition by doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified