Ovarian CancerPhase 1NCT04701645
Microdevice In Ovarian, Fallopian Tube, And Peritoneal Cancer
A Phase 1 study testing Microdevice in people with Ovarian Cancer and Fallopian Tube Cancer, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer. The name of the study intervention involved in this study is: -implantable microdevice Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
- What is being tested?
- Microdevice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2022to 30 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.
- Participants must meet one of the following clinical categories:
- Cohort 1: Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
- Cohort 2: Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.
- Cohort 3: Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g. to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions.
- Cohort 4: Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
Show all 25Show fewer
- Participants must be 18 years of age or older.
- Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.
- Participants will undergo laboratory testing within 14 days* prior to the microdevice placement.
- Patients must have absolute neutrophil count ≥ 1,500/mcL
- Platelets ≥ 75,000/mcL
- PT (INR) < 1.5
- PTT < 1.5x control
- Women of childbearing potential must have negative pregnancy test (urine or serum) **Cohort 4 patients should undergo laboratory testing within 7 days prior to the microdevice placement
- Participants must be evaluated by a surgical gynecologic oncologist who will determine the clinically appropriate treatment strategy (primary surgery or neoadjuvant chemotherapy) based on clinical history and extent of disease. The patient's surgical and/or medical gynecologic oncologist must also confirm the patient's medical fitness to undergo an additional biopsy procedure and the indicated surgical procedure. The patient must have a plan to undergo surgery for clinical purposes.
- The following criteria must be met:
- Participants must have undergone an abdominal/pelvic CT scan that both assesses the extent of disease and identifies an area of tumor amenable to safe microdevice placement. CT scans with both oral and IV contrast media are preferred but not required.
- CT scans performed at outside institutions are acceptable providing that the images are considered adequate to assess the stage of the disease and to assess the safety and feasibility of the placement of the microdevices and their retrieval during standard-of care surgery. CT scan must be completed within 4 weeks prior to the microdevice placement.
- Patient has sufficient volume of disease as measured by CT scan to allow implantation of the microdevice.
- Patient has sufficient volume of disease that removal of the lesion where the microdevice is placed will not potentially affect adequate tissue for diagnosis.
- A lesion can be selected where the microdevice is to be implanted that is
- Amenable to percutaneous placement
- Amenable to removal at the time of surgery or laparoscopy. If patient is undergoing laparoscopy, the lesion must be able to be removed using a laparoscopic approach in a manner that would not significantly alter the procedure or affect patient safety, per opinion of the surgical oncologist.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Patients must be willing to undergo research-related genetic sequencing (somatic and germline) and data management, including the deposition of de-identified genetic sequencing data in NIH central data repositories.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy/device placement in an abdominal lesion.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
- Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Madeline Polak, BS contact
United States2 sites, 2 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Elizabeth Stover, MD, PhD, (617) 632-5269, ehstover@partners.org
Elizabeth Stover, MD, PhD
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Elizabeth Stover, MD, PhD, (617) 632-5269, ehstover@partners.org
Elizabeth Stover, MD, PhD
About this study
Official title: Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer
This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
The name of the study intervention involved in this study is:
-implantable microdevice
Read the detailed description
This research study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
Participants with suspected or confirmed ovarian cancer whose treatment plan includes surgery as a component of standard-of-care treatment will be identified.
-The research study procedures include screening for eligibility and study treatment including evaluations and follow-up.
The name of the study intervention involved in this study is: implantable microdevice
- Participant will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
- It is expected that about 20 people will take part in this research study.
This research study is a Pilot Study, which is the first time investigators are examining this microdevice. The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a tool to identify which cancer treatment is best for any disease.
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV
- Being tested
- Microdevice
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Implantable Microdevice, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancer Stage III
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrodeviceCombination product
Placement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain.
- Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer.
- Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only.
- Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Primary cytoreduction | Experimental | Patients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. Receives: Combination Product: Microdevice |
| Cohort 2: Surgical assessment for primary surgery | Experimental | Patients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery.
* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. Receives: Combination Product: Microdevice |
| Cohort 3: Secondary cytoreduction | Experimental | Patients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g.to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions.
* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. Receives: Combination Product: Microdevice |
| Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy | Experimental | Patients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery.
* Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery.
* The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. Receives: Combination Product: Microdevice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as defined in the CTCAE v5.0
Descriptive statistics will be used to evaluate the safety of microdevice placement and removal, including reporting the maximum grade AE by type and organ class with 95% binomial confidence intervals.
Measured: Up to 2 months
Number of implanted microdevices successfully retrieved
Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each microdevice considered to be relatively independent in terms of placement, retrieval, and analysis.
Measured: Up to 32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Nov 2022
- Primary completion5 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Oliver Jonas, Brigham and Women's Hospital
- Investigators
- Elizabeth Stover, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04701645
- Sponsor's protocol ID
- 20-357
- Other IDs
- R21CA216796
- Status last verified
- May 2026
- First submitted
- 8 Oct 2020
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Implantable Microdevice for Evaluating Drug Responses in Situ in Ovarian, Fallopian Tube, and Peritoneal Cancer
- ClinicalTrials.gov ID
- NCT04701645
- Acronym / sponsor ID
- 20-357
- Conditions
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV
- Keywords
- Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer, Implantable Microdevice, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Fallopian Tube Cancer Stage IV, Fallopian Tube Cancer Stage III
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Dana-Farber Cancer Institute
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 5 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 Jan 2021 (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.
This pilot study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
The name of the study intervention involved in this study is:
-implantable microdevice
Detailed description
This research study will assess the feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in ovarian, fallopian tube, and primary peritoneal cancer.
Participants with suspected or confirmed ovarian cancer whose treatment plan includes surgery as a component of standard-of-care treatment will be identified.
-The research study procedures include screening for eligibility and study treatment including evaluations and follow-up.
The name of the study intervention involved in this study is: implantable microdevice
- Participant will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure.
- It is expected that about 20 people will take part in this research study.
This research study is a Pilot Study, which is the first time investigators are examining this microdevice. The FDA (the U.S. Food and Drug Administration) has not approved the microdevice as a tool to identify which cancer treatment is best for any disease.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Primary cytoreduction | Experimental | Combination Product: MicrodevicePatients with a new or suspected diagnosis of ovarian cancer who are deemed surgical candidates for primary cytoreductive surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery. * Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. * The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. |
| Cohort 2: Surgical assessment for primary surgery | Experimental | Combination Product: MicrodevicePatients with newly diagnosed ovarian cancers who are being considered for either primary surgery or neoadjuvant chemotherapy by their surgical gynecologic oncologist, and who require a laparoscopic procedure to determine their candidacy for surgery. * Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. * The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. |
| Cohort 3: Secondary cytoreduction | Experimental | Combination Product: MicrodevicePatients with recurrent ovarian cancer who are candidates for secondary cytoreduction, e.g.to confirm diagnosis of recurrent ovarian cancer and/or remove oligometastatic lesions. * Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. * The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. |
| Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy | Experimental | Combination Product: MicrodevicePatients with newly diagnosed ovarian cancers who have undergone neoadjuvant chemotherapy and are deemed surgical candidates for interval debulking surgery (as per their surgical gynecologic oncologist) and who have not yet undergone surgery. * Participants will undergo percutaneous placement of several microdevices in a selected tumor deposit prior to surgery. * The microdevices will dwell in the tumor tissue for approximately 24 +/- 8 hours to allow time for tissue effects of the drugs in the microdevice reservoirs. Microdevices will then be removed by resection of the tumor mass during a previously planned, and clinically indicated, surgical procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must have suspected or confirmed clinically advanced stage (III-IV, defined as disease outside of the pelvis) ovarian, fallopian tube, or peritoneal cancer. If a patient has suspected ovarian cancer but final histologic analysis does not show evidence of ovarian cancer, the patient will be removed from the study and replaced.
- Participants must meet one of the following clinical categories:
- Participants must be 18 years of age or older.
- Patients must be deemed medically stable to undergo both percutaneous procedures and standard-of-care surgical procedures by their treating gynecologic oncologist and medical oncologist.
- Participants will undergo laboratory testing within 14 days* prior to the microdevice placement.
Key exclusion criteria (4 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit the safety of a biopsy and/or surgery.
- Pregnant women are excluded from this study because of the possible increased dose of radiation from imaging associated with the microdevice placement and the potential risk to the pregnancy of the biopsy/device placement in an abdominal lesion.
- Uncorrectable bleeding or coagulation disorder known to cause increased risk with surgical or percutaneous biopsy procedures.
- Significant risk factors (including, but not limited to, high risk of venous thrombosis, pulmonary embolism, stroke or myocardial infarction) precluding the safe cessation of anticoagulation medication as per SIR guidelines. (Patients taking low-dose aspirin only do not need to be excluded.)
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 |
|---|---|---|
| MicrodevicePlacement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain. * Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer. * Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only. * Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination) | Combination product | Cohort 1: Primary cytoreduction, Cohort 2: Surgical assessment for primary surgery, Cohort 3: Secondary cytoreduction, Cohort 4: Interval debulking surgery following neoadjuvant chemotherapy |
Primary outcome
Number of participants with adverse events as defined in the CTCAE v5.0
Time frame: Up to 2 months
Descriptive statistics will be used to evaluate the safety of microdevice placement and removal, including reporting the maximum grade AE by type and organ class with 95% binomial confidence intervals.
Number of implanted microdevices successfully retrieved
Time frame: Up to 32 hours
Defined as the ability to retrieve the microdevice with sufficient tissue, of sufficient quality, for downstream histopathology analysis and interpretation of at least 50% of the microdevice reservoirs. For purposes of this endpoint, feasibility will be assessed on a per-device basis rather than a per-patient basis, with each microdevice considered to be relatively independent in terms of placement, retrieval, and analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Madeline Polak, BS contact
Elizabeth Stover, MD, PhD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microdevice in people with Ovarian Cancer and Fallopian Tube Cancer, run by Brigham and Women's Hospital at 2 sites in United States.
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 25 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Stover, MD, PhD ((617) 632-5269, ehstover@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events as defined in the CTCAE v5.0 (time frame: Up to 2 months). The study lists 2 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 18 May 2026.