HIPECNCT04664218
Are You in a Poor Country; HIPEC is Still in Reach
A study testing HIPEC device in people with HIPEC, run by Zagazig University.
Trial summary
Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- HIPEC
- What is being tested?
- HIPEC device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient candidate for HIPEC procedure
Who cannot join
- Contraindications to HIPEC procedure
About this study
Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.
On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.
A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.
Read the detailed description
As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines
- Conditions
- HIPEC
- Being tested
- HIPEC device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPEC deviceDevice
To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.
| Study group | Role | What they receive |
|---|---|---|
| patients with Peritoneal carcinomatosis | Experimental | Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy. Receives: Device: HIPEC device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thermal efficiency of the machine
The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion)
Measured: 6 years of the study using the machine
Electrical efficiency of the machine
Reporting any interruption or unexplained stop of the thermostat resulting in stopping of chemoperfusate flow to and out of the abdomen during the 90 minutes of the maneuver
Measured: 6 years of the study using the machine
The manufacturing costs in US dollar
the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine
Measured: one weak at the start of the trial
The disposable costs in US dollar
the costs spent by the patient at each use paid for the disposable parts of the machine of the chemotherapy perfusion circuit to and from the patient
Measured: 6 years of the study using the machine
Secondary outcomes (1)
Adverse effects on the patient following HIPEC
following the patient in the postoperative period searching for adverse effects of HIPEC resulting from either the chemotherapy used or the physical activity of the machine
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study startJan 2014
- Primary completionJan 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIPECStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed I Abdelhamid, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664218
- Sponsor's protocol ID
- HIPEC is still in reach 2020
- Status last verified
- Dec 2020
- First submitted
- 24 Oct 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are You in a Poor Country; HIPEC is Still in Reach
- ClinicalTrials.gov ID
- NCT04664218
- Acronym / sponsor ID
- HIPEC is still in reach 2020
- Conditions
- HIPEC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- Jan 2014 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Peritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy.
On introduction of the new concept of combined optimal cytoreduction (CRS) followed by hyperthermic intraperitoneal chemotherapy (HIPEC), promising prognosis began to be shown.
A major obstacle which may face application of HIPEC manoeuvre is the cost either of the machine or the disposable kit used in handling the chemotherapy, heating it and delivering it to the patient, hence we established our machine design with its disposable kits making it available for use in poor places.
Detailed description
As aforementioned the use of HIPEC technique offered a promising results in dealing with peritoneal carcinomatosis the high costs seems to be a considerable obstacle in some poor places so we inented a machine with considerably lower costs both in the machine composition and its disposable kit used for every patient we used it for six years in a trial to find any shortage, obstacles or any technical, therapeutic or financial drawbacks compared to the published data of the standard machines
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with Peritoneal carcinomatosis | Experimental | Device: HIPEC devicePeritoneal carcinomatosis (PC) is a well-known sequel of multiple abdominal malignancies either arising from the gastro-intestinal tract or of gynaecologic origin. On occurrence, PC is mostly considered as a very bad prognostic sign hence it affects the overall survival with very poor response to systemic chemotherapy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient candidate for HIPEC procedure
Key exclusion criteria (1 listed)
- Contraindications to HIPEC procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPEC deviceTo report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places. | Device | patients with Peritoneal carcinomatosis |
Primary outcome
Thermal efficiency of the machine
Time frame: 6 years of the study using the machine
The ability of the machine to warm the chemoperfusate to 43 c for 90 minutes (the duration of peritoneal perfusion)
Electrical efficiency of the machine
Time frame: 6 years of the study using the machine
Reporting any interruption or unexplained stop of the thermostat resulting in stopping of chemoperfusate flow to and out of the abdomen during the 90 minutes of the maneuver
The manufacturing costs in US dollar
Time frame: one weak at the start of the trial
the costs paid by the owner of manufacturing the machine throughout collecting its components and technical fitting them into a machine
The disposable costs in US dollar
Time frame: 6 years of the study using the machine
the costs spent by the patient at each use paid for the disposable parts of the machine of the chemotherapy perfusion circuit to and from the patient
1 secondary outcome
Adverse effects on the patient following HIPEC
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
Related trials for HIPEC
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
Not yet recruitingPhase 2
Application of Intraperitoneal Hyperthermic Chemotherapy in the Treatment of Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (Diagnosis)
Not yet recruitingObservational study
Cost-utility Evaluation of Cytoreductive Surgery With or Without Mitomycin-C Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for Resectable Colorectal Peritoneal Metastases
Hyperthermic Intraperitoneal Chemotherap, Colorectal Cancer Metastatic
Active, not recruitingPhase 1
Surgery and Chemotherapy With or Without Chemotherapy After Surgery in Treating Patients With Ovarian, Fallopian Tube, Uterine, or Peritoneal Cancer
FIGO Stage IVA Ovarian Cancer, FIGO Stage IVB Ovarian Cancer
RecruitingPhase 2
HIPEC Priming Followed by Serplulimab Plus SOX/XELOX in Locally Advanced Gastric Cancer
Locally Advanced Gastric Cancer, Gastric Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HIPEC device in people with HIPEC, run by Zagazig University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermal efficiency of the machine (time frame: 6 years of the study using the machine). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.