Clinical Investigation

A clinical study to evaluate Héra.

Athana is launching a clinical trial at the Institut Rafaël, under the scientific direction of Professor Alain Toledano, to assess the effect of localized cryotherapy on hot flashes.

Seen on TV

Professor Alain Toledano presents the Héra clinical trial

Our Approach

Check before making a claim.

Héra soothes the sensation of heat with cold, and thousands of people use it every day. To go beyond this subjective experience, we decided to have the device evaluated in a scientific setting.

This requires a written protocol submitted to health authorities, validated measurement instruments, and an independent research center. This is the path we have embarked upon, and we will publish our findings, whatever they may be.

50participants included
3months of device use
9months total duration of study
4Validated measurement scales
The protocol

A method, not a hunch

A prospective, single-center, non-comparative clinical study conducted at the Cancer Coordination Center (3C) of the Hartmann Institute / Rafaël Institute.

1

Inclusion · M0

Informed consent, initial questionnaires, and device handoff.

2

Progress · Week 2

Phone call to discuss getting started and tolerance.

3

Evaluation · Month 1.5

Interim inspection: data collection and safety checks.

4

End of Participation · Month 3

Final questionnaires and completion of individual follow-up.

Participants: 50 adult volunteers, followed for 3 months.
Inclusion Criteria: Adultsaged 18 and older who have been on hormone therapy for at least 6 months, experience bothersome hot flashes, and have signed an informed consent form.
Exclusion Criteria: Cold intolerance, severe cognitive impairment, participation in another ongoing study.
The Instruments

What the study measures

Four recognized scales used in international clinical research.

Primary criterion

Hot Flash Diary

The go-to journal for recording, day by day, the frequency and intensity of hot flashes. This measurement forms the basis of the primary evaluation criterion.

Secondary criterion

HFIS

Hot Flash Interference Scale: measures the actual impact of hot flashes on daily activities, mood, and relationships.

Secondary criterion

PSQI

Pittsburgh Sleep Quality Index: assesses sleep quality, one of the most commonly impaired aspects of daily life.

Secondary criterion

EORTC QLQ-C30

A quality-of-life questionnaire developed by the European Organization for Cancer Research and Treatment, used worldwide.

The principal investigator
We lacked a non-pharmacological treatment that could be clinically evaluated. Our goal is to scientifically evaluate the efficacy and tolerability of Héra in order to provide robust clinical data for women suffering from hot flashes.

Professor Alain Toledano

President of the Rafaël Institute · Oncologist · Principal Investigator of the Héra clinical trial

Regulatory Framework

A supervised study, from the first day to the last

Regulation (EU) 2017/745 ISO 14155 (Good Clinical Practice) Declaration of Helsinki CPP Opinion ANSM Notification GDPR Compliance Informed Consent Anonymized Data
Transparency

What is the current status of the study?

Step 1 Protocol drafted
Step 2 Submission to CPP and ANSM
Step 3 Inclusion of Participants
Step 4 Analysis and Publication

The study is currently undergoing regulatory review: the protocol has been submitted to the Committee for the Protection of Human Subjects (CPP) and the ANSM. No participants have been enrolled yet, and no results are available at this time. We will publish the findings on this page, whatever they may be.

Frequently Asked Questions

What You Need to Know

Is Héra a medical device?
No. Héra is a portable cryotherapy device designed for comfort and is not marketed as a medical device. The clinical investigation currently underway is specifically intended to generate clinical data within a controlled setting.
Has Héra's effectiveness been clinically proven?
Not at this time, and we prefer to be clear about that. That is the whole point of this process: no clinical data has been generated yet, and we refuse to announce a result before it exists.
Who is funding the study?
Athana is the sponsor of the study and is providing the funding. The study is being conducted by a hospital-based team under the scientific direction of Professor Alain Toledano.
When will the results be announced?
The protocol calls for 3 months of use per participant, for a total duration of approximately 9 months from the actual start date, which is itself contingent on regulatory approvals.
Can I participate in the study?
Enrollment has not yet begun. Recruitment is handled exclusively by the investigator site, based on specific medical criteria: Athana does not select any participants.

French technology, designed for everyday use.

Héra relieves the sensation of heat in just a few seconds using localized cryotherapy. Compact, rechargeable, made in France.

Discover Hera

Héra is a portable cryotherapy device designed to promote comfort and well-being. It is not a medical device and is not a substitute for medical advice, diagnosis, or treatment. The clinical study described on this page is currently undergoing the regulatory review process: it has not produced any results to date and does not constitute proof of efficacy. For any health-related questions, consult a healthcare professional.