Intrauterine AdhesionNCT07032506
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
A study testing Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement and Hormonal Therapy Agent in people with Intrauterine Adhesion, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement and Hormonal Therapy Agent
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 May 2026to 31 Dec 2031
- Phase
- Interventional
- 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
- Age 18 and above
- Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
- Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound
Who cannot join
- Unwilling or unable to provide informed consent
- History of prior uterine septum resection
- History of prior transmural uterine surgery
- Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
- Individuals in whom complete septum resection is unable to be performed as a single procedure
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
University Hospitals
Cleveland, Ohio, 44195
Mindy Christianson, MD, (216) 672-1427, christm12@ccf.org
Christianson, MD
- Not yet recruiting
Arkansas Fertility & Gynecology
Little Rock, Arkansas, 72205-0000
Christopher Moutos, MD, (501) 534-3764, res2011@med.cornell.edu
Christopher Moutos, MD
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Rodriq Stubbs, NP, res2011@med.conrell.edu
Glenn Schattman, MD
About this study
Official title: A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.
Read the detailed description
This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.
Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:
Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.
- Conditions
- Intrauterine Adhesion
- Being tested
- Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement, Hormonal Therapy Agent, Oral antibiotics
- Keywords
- intrauterine foley balloon catheter stent, uterine malformations, uterine septums, hysteroscopic septoplasty
- Medical subject headings
- Gynatresia, Uterine Anomalies, Septate Uterus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative placement of an inflated intrauterine pediatric foley catheterProcedure or surgery
Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery.
No Catheter placementProcedure or surgery
No Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon
Hormonal Therapy AgentDrug
2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily)
Oral antibioticsDrug
100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place
| Study group | Role | What they receive |
|---|---|---|
| Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter | Experimental | Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery. Receives: Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter; Drug: Hormonal Therapy Agent; Drug: Oral antibiotics |
| Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter | Active comparator | No placement of an inflated intrauterine pediatric foley catheter Receives: Procedure: No Catheter placement; Drug: Hormonal Therapy Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of intrauterine adhesion formation following hysteroscopic septoplasty
Measured: 12 weeks
Secondary outcomes (6)
Number of participants with Intraoperative complications
Measured: 12 weeks
Number of participants with postoperative complications
Measured: 12 weeks
Number of subjects completing postop intervention-hormone use
Measured: 12 weeks
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit
Measured: 12 weeks
Long Term Reproductive Outcome
Number of subjects achieving pregnancy
Measured: 3 years
Surgeon assessment of intervention modality
Surgeon assessment of whether intrauterine adhesions were prevented
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start14 May 2026
- Primary completion30 Sep 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Schattman, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032506
- Sponsor's protocol ID
- 24-04027291
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intrauterine Stent Placement Following Hysteroscopic Septum Resection
- ClinicalTrials.gov ID
- NCT07032506
- Acronym / sponsor ID
- 24-04027291
- Conditions
- Intrauterine Adhesion
- Keywords
- intrauterine foley balloon catheter stent, uterine malformations, uterine septums, hysteroscopic septoplasty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 24 Jun 2025 (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.
The study hopes to learn the best way to prevent internal scar tissue after septum removal. The use of an intrauterine foley catheter balloon may prevent the formation of adhesions following surgery.
Detailed description
This is an open label randomized controlled clinical trial of post-operative interventions to prevent intrauterine adhesion formation following hysteroscopic septoplasty. Individuals undergoing planned hysteroscopic resection of a known uterine septum with a length of ≥50% of the uterine cavity, as measured from the lower uterine segment to the inter-cornual line on 3D ultrasound or MRI will be randomized to either placement of an intrauterine foley catheter balloon for 7-10 days with hormonal supplementation or hormonal supplementation only. Individuals unwilling or unable to consent, those with a history of prior transmural uterine surgery, those with a history of a prior septum resection, history of prior surgery for intrauterine adhesions, or individuals in whom complete septum resection is unable to be performed in a single procedure will be excluded.
Patients will be screened by study investigators for eligibility. Patients will be identified if they are found to have a uterine septum during their evaluation for infertility or recurrent pregnancy loss or if previously identified by a referring provider. Investigators will obtain written informed consent in the patient's preferred language by person-to-person contact. Patients choosing to enroll will be randomized in a 1:1 allocation to one of two interventions:
Surgical technique in the form of electrocautery versus sharp resection will be at the surgeon's discretion. All patients will undergo a post-operative in-clinic 3D saline sonogram to assess adhesion formation within the first two menstrual cycles following the intervention, to be performed no later than 12 weeks following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter | Experimental | Procedure: Intraoperative placement of an inflated intrauterine pediatric foley catheter, Drug: Hormonal Therapy Agent, Drug: Oral antibioticsIntraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery. |
| Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter | Active comparator | Procedure: No Catheter placement, Drug: Hormonal Therapy AgentNo placement of an inflated intrauterine pediatric foley catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above
- Patients electing to undergo hysteroscopic septoplasty following an informed consent and shared decision making process
- Uterine septum of at least 50% of the uterine cavity length as quantified on 3-dimensional saline infusion ultrasound
Key exclusion criteria (5 listed)
- Unwilling or unable to provide informed consent
- History of prior uterine septum resection
- History of prior transmural uterine surgery
- Preexisting intrauterine adhesions or prior treatment for intrauterine adhesions
- Individuals in whom complete septum resection is unable to be performed as a single 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 |
|---|---|---|
| Intraoperative placement of an inflated intrauterine pediatric foley catheterIntraoperative placement of an inflated intrauterine pediatric foley catheter balloon to remain in place for 7-10 days following surgery. | Procedure or surgery | Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter |
| No Catheter placementNo Intraoperative placement of an inflated intrauterine pediatric foley catheter balloon | Procedure or surgery | Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter |
| Hormonal Therapy Agent2 weeks of oral estradiol (2 mg daily) or transdermal (two 0.1 mg patches changed twice weekly) estradiol supplementation followed by 1 week of oral or transdermal estradiol (same dosing as above) with oral medroxyprogesterone acetate (10 mg daily) | Drug | Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter, Intervention B: No placement of placement of an inflated intrauterine pediatric foley catheter |
| Oral antibiotics100 mg of oral doxycycline twice daily or other appropriate antibiotic in allergic patients to be given while the intrauterine stent is in place | Drug | Intervention A:Intraoperative placement of an inflated intrauterine pediatric foley catheter |
Primary outcome
The rate of intrauterine adhesion formation following hysteroscopic septoplasty
Time frame: 12 weeks
6 secondary outcomes
Number of participants with Intraoperative complications
Time frame: 12 weeks
Number of participants with postoperative complications
Time frame: 12 weeks
Number of subjects completing postop intervention-hormone use
Time frame: 12 weeks
Patient compliance - Post Operative - #subject with balloon remaining in place to post op visit
Time frame: 12 weeks
Long Term Reproductive Outcome
Time frame: 3 years
Surgeon assessment of intervention modality
Time frame: 12 weeks
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 12 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Glenn Schattman, MD principal investigator
Weill Medical College of Cornell University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative placement of an inflated intrauterine pediatric foley catheter, No Catheter placement and Hormonal Therapy Agent in people with Intrauterine Adhesion, run by Weill Medical College of Cornell University at 3 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 3 inclusion and 5 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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 Rodriq Stubbs, NP, MSN (646-962-3276, res2011@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of intrauterine adhesion formation following hysteroscopic septoplasty (time frame: 12 weeks). 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 12 Jun 2026.